CN111918688B

CN111918688B - Connector assembly

Info

Publication number: CN111918688B
Application number: CN201980015159.1A
Authority: CN
Inventors: L·E·克林肯伯格
Original assignee: Resmed Pty Ltd
Current assignee: Resmed Pty Ltd
Priority date: 2018-02-02
Filing date: 2019-02-01
Publication date: 2023-07-25
Anticipated expiration: 2039-02-01
Also published as: US11833307B2; CN111918688A; MX2020008052A; WO2019148243A1; CN117065168A; JP2021511886A; EP3746163A4; EP4378510A2; US20210030990A1; EP3746163B1; JP7193543B2; EP4378510A3; EP3746163A1

Abstract

A patient interface for delivering an air flow at a positive pressure relative to ambient air pressure to an entrance to an airway of a patient while the patient is asleep to ameliorate sleep disordered breathing includes a positioning and stabilizing structure that forms a seal with an area of the patient's face surrounding the entrance to the airway of the patient, provides a force that maintains the seal-forming structure in a therapeutically effective position on the patient's head, and a connector assembly adapted for connection to an air circuit. The connector assembly includes a ring member removably and releasably secured in an aperture of an attachment region of the patient interface and an elbow assembly connected to the air circuit and repeatedly connected to and disconnected from the ring member. The elbow assembly includes an elbow member and a clamp member. The clip member includes a separate and distinct structure from the elbow member and is connected to the elbow member and releasably connects the elbow assembly to the ring member, the elbow member forming a seal with the ring member when the elbow assembly and the ring member are connected to each other.

Description

Connector assembly

A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the patent office patent document or the records, but reserves all copyright rights whatsoever.

Cross reference to related application 1

The present application claims the benefit of U.S. provisional application No. 62/625,571, filed on 2 months 2018, the entire contents of which are incorporated herein by reference.

2 background art

2.1 technical field

The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory related disorders. The present technology also relates to medical devices or apparatus and uses thereof.

2.2 description of related Art

2.2.1 human respiratory System and disorders thereof

The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

The airways include a series of branches that become narrower, shorter and more numerous as the branch airways penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter venous blood from the inhaled air and to expel carbon dioxide in the opposite direction. The trachea is divided into left and right main bronchi, which are ultimately subdivided into terminal bronchioles. The bronchi constitute the airway and do not participate in gas exchange. Further airway division results in respiratory bronchioles and ultimately alveoli. The alveolar region of the lung is where gas exchange occurs and is known as the respiratory tract. See respiratory physiology (Respiratory Physiology), 9 th edition published by John b.west, lippincott Williams & Wilkins in 2012.

There are a range of respiratory diseases. Certain disorders may be characterized by specific events such as apneas, hypopneas, and hyperbreaths.

Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), tidal breathing (CSR), respiratory insufficiency, obesity Hyperventilation Symptoms (OHS), chronic Obstructive Pulmonary Disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

Obstructive Sleep Apnea (OSA) is a form of Sleep Disordered Breathing (SDB) characterized by events that include occlusion or blockage of the upper airway during sleep. This is caused by abnormally small upper airways in the tongue, soft palate and posterior oropharyngeal wall areas plus normal loss of muscular tone during sleep. The condition causes the affected patient to stop breathing, typically for a period of 30 seconds to 120 seconds, sometimes 200 to 300 times per night. It often causes excessive daytime sleepiness, and may lead to cardiovascular disease and brain damage. Although the affected person may not be aware of the problem, the symptom is an obstacle that is common in overweight men, especially in middle-aged people. See U.S. Pat. No. 4,944,310 (Sullivan).

Tidal breathing (CSR) is another form of sleep disordered breathing. CSR is a disorder of the respiratory controller of a patient in which there are rhythmic alternating periods of exuberant and reduced ventilation called CSR circulation. CSR is characterized by repeated deoxygenation and reoxidation of arterial blood. CSR can be detrimental due to repeated hypoxia. For some patients, CSR is associated with repeated arousal from sleep, which results in severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Pat. No. 6,532,959 (Berthon-Jones).

Respiratory failure is a term for respiratory system disorders in which the lungs cannot inhale enough oxygen or exhale enough CO ₂ To meet the needs of the patient. Respiratory failure may encompass some or all of the following disorders.

Patients with respiratory insufficiency, a form of respiratory failure, may experience abnormal shortness of breath while exercising.

Obesity Hyperventilation Syndrome (OHS) is defined as a combination of severe obesity and awake chronic hypercapnia in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headaches, and daytime sleepiness.

Chronic Obstructive Pulmonary Disease (COPD) includes any of a group of lower airway diseases that share some common features. These include increased resistance to air movement, prolonged expiratory phases of respiration, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (major risk factor), occupational exposure, air pollution and genetic factors. Symptoms include exertion dyspnea, chronic cough, and excessive phlegm.

Neuromuscular disease (NMD) is a broad term that includes many diseases and afflictions that impair muscle function either directly by intrinsic muscle pathology or indirectly by neuropathology. Some NMD patients are characterized by progressive muscle damage that results in loss of walking ability, wheelchair binding, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified into fast-progression and slow-progression: (i) fast-evolving disorder: characterized by muscle damage that worsens within months and results in death within years (e.g., juvenile Amyotrophic Lateral Sclerosis (ALS) and Duchenne Muscular Dystrophy (DMD); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens for years and that only slightly reduces life expectancy (e.g., limb girdles, shoulder humerus and myotonic muscular dystrophies). Symptoms of respiratory failure in NMD include increased generalized weakness, dysphagia, dyspnea with exertion and rest, fatigue, somnolence, morning headaches, and difficulties with attention and mood changes.

Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the chest cage. These disorders are often characterized by restrictive defects and have the potential for long-term hypercarbonated respiratory failure. Scoliosis and/or kyphosis can lead to severe respiratory failure. Symptoms of respiratory failure include: dyspnea, peripheral edema, sitting breathing, recurrent chest infections, morning headache, fatigue, poor sleep quality and loss of appetite.

A range of treatments have been used to treat or ameliorate such conditions. In addition, other healthy individuals can utilize such treatments to prevent the occurrence of respiratory disorders. However, these have a number of disadvantages.

2.2.2 treatment

Various therapies, such as Continuous Positive Airway Pressure (CPAP) therapy, non-invasive ventilation (NIV), and Invasive Ventilation (IV) have been used to treat one or more of the respiratory disorders described above.

Continuous Positive Airway Pressure (CPAP) has been used to treat Obstructive Sleep Apnea (OSA). The mechanism of action is continuous positive airway pressure, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall, as a pneumatic splint and may prevent upper airway obstruction. Treatment of OSA by CPAP therapy may be voluntary, so if the patient finds the means for providing such treatment to be: any one or more of uncomfortable, difficult to use, expensive, and unsightly: uncomfortable, difficult to use, expensive, and aesthetically undesirable.

Non-invasive ventilation (NIV) provides ventilation support to a patient through the upper airway to assist the patient in breathing and/or to maintain adequate oxygen levels in the body by performing some or all of the respiratory effort. The ventilation support is provided via a non-invasive patient interface. NIV has been used in the treatment of CSR and respiratory failure in forms such as OHS, COPD, NMD and chest wall disorders. In some forms, the comfort and effectiveness of these treatments may be improved.

Invasive Ventilation (IV) provides ventilation support for patients who are no longer able to breathe effectively themselves, and may be provided using tracheostomy tubes. In some forms, the comfort and effectiveness of these treatments may be improved.

2.2.3 treatment System

These therapies may be provided by a treatment system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it.

The therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

Another form of treatment system is a mandibular repositioning device.

2.2.3.1 patient interface

The patient interface may be used to connect the breathing apparatus to its wearer, for example by providing an air flow to an inlet of the airway. The air flow may be provided into the patient's nose and/or mouth via a mask, into the mouth via a tube, or into the patient's trachea via an autogenous cutting tube. Depending on the treatment to be applied, the patient interface may form a seal with an area, such as the patient's face, facilitating the gas to be at a pressure that is sufficiently different from ambient pressure (e.g., about 10cmH relative to ambient pressure ₂ Positive pressure of O) to effect treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include sufficient to facilitate about 10cmH ₂ The gas supply at positive pressure of O is delivered to the seal of the airway.

Some other mask systems may not be functionally suitable for use in the art. For example, a purely decorative mask may not be able to maintain proper pressure. Mask systems for underwater swimming or diving may be configured to prevent ingress of water at higher pressure from the outside, but not to maintain the internal air at a pressure above ambient pressure.

Certain masks may be clinically disadvantageous to the present technique, for example if they block the flow of air through the nose and only allow it to pass through the mouth.

If some masks require a patient to insert a portion of the mask structure into their mouth to create and maintain a seal with their lips, it may be uncomfortable or impractical for the present technique.

Some masks may not be practical for use while sleeping, such as when the head is lying on its side on a soft pillow and sleeping in a bed.

The design of patient interfaces presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of the nose varies significantly from person to person. Since the head includes bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces. The jawbone or mandible may be moved relative to the other bones of the skull. The entire head may be moved during respiratory therapy.

Because of these challenges, some masks face one or more of the following problems: abrupt, unsightly, expensive, incompatible, difficult to use, especially when worn for extended periods of time or uncomfortable for the patient when not familiar with the system. Wrong sized masks may lead to reduced compliance, reduced comfort, and poor patient outcome. Masks designed for pilots only, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for applying anesthetic agents are acceptable for their original application, but such masks are not ideal as comfortable for wearing for long periods of time (e.g., several hours). Such discomfort may lead to reduced patient compliance with the treatment. This is especially true if the mask is worn during sleep.

CPAP therapy is very effective in treating certain respiratory disorders, provided that the patient is compliant with the therapy. Patients may not be compliant with treatment if the mask is uncomfortable or difficult to use. Since patients are often advised to regularly clean their masks, if the masks are difficult to clean (e.g., difficult to assemble or disassemble), the patients may not clean their masks, which may affect patient compliance.

While masks for other applications (e.g., navigator) may not be suitable for treating sleep disordered breathing, masks designed for treating sleep disordered breathing may be suitable for other applications.

For these reasons, patient interfaces for delivering CPAP during sleep form a different field.

2.2.3.1.1 seal forming structure

The patient interface may include a seal-forming structure. Because the seal-forming structure is in direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

The patient interface may be characterized in part by the design intent of the seal-forming structure to engage the face in use. In one form of patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left naris and a second sub-portion that forms a seal around the right naris. In one form of patient interface, the seal-forming structure may comprise a single element that, in use, surrounds both nostrils. Such a single element may be designed to cover, for example, the upper lip region and the nasal bridge region of the face. In one form of patient interface, the seal-forming structure may comprise an element that in use surrounds the mouth region, for example by forming a seal on the lower lip region of the face. In one form of patient interface, the seal-forming structure may comprise a single element that in use surrounds both nostrils and the mouth region. These different types of patient interfaces may be variously named by their manufacturers, including nasal masks, full face masks, nasal pillows, nasal sprays, and oral nasal masks.

A seal-forming structure that may be effective in one region of a patient's face may not fit in another region, for example, because of the differences in shape, structure, variability, and sensitive areas of the patient's face. For example, seals on swimming goggles covering the forehead of a patient may not be suitable for use over the nose of a patient.

Certain seal-forming structures may be designed for mass production so that one design is suitable and comfortable and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-produced patient interface, one or both must be accommodated to form a seal.

One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface while the seal-forming portion is in face-to-face engagement with the patient's face. The seal-forming structure may comprise an air or fluid filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer such as rubber. For this type of seal-forming structure, if there is insufficient fit, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to effect a seal.

Another type of seal-forming structure incorporates a sheet-like seal of thin material positioned around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous forms of seal formation, if the fit between the face and mask is not good, additional force may be required to achieve the seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may buckle or bend during use, resulting in leakage.

Another type of seal-forming structure may include friction-fit elements, for example, for insertion into nostrils, however some patients find these uncomfortable.

Another form of seal-forming structure may use an adhesive to effect the seal. Some patients may find it inconvenient to apply and remove adhesive from their face often.

A series of patient interface seal forming structural techniques are disclosed in the following patent applications assigned to ResMed Limited: WO 1998/004,310; WO 2006/074,513; WO 2010/135,785.

One form of nasal pillow is found in Adam Circuit (Adam Circuit) manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Pat. No. 4,782,832 (Trimble et al) assigned to Puritan-Bennett Corporation.

ResMed Limited manufactured the following nasal pillow-bonded product: SWIFT ^TM Nasal pillow mask, SWIFT ^TM II nasal pillows mask, SWIFT ^TM LT nasal pillow mask, SWIFT ^TM FX nasal pillow mask and MIRAGE LIBERTY ^TM A full face mask. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: international patent application WO 2004/073,778 (especially describing ResMed Limited SWIFT) ^TM Aspects of nasal pillows), U.S. patent application 2009/0044808 (describing, inter alia, resMed Limited SWIFT) ^TM LT nasal pillow aspect); international patent applications WO 2005/063,328 and WO 2006/130,903 (ResMed Limited MIRAGE LIBERTY is described therein ^TM Aspects of the full face mask); international patent application WO 2009/052,560 (wherein ResMed Limited SWIFT is described ^TM Other aspects of FX nasal pillows).

2.2.3.1.2 positioning and stabilization

The seal-forming structure of a patient interface for positive air pressure therapy is subjected to a corresponding force of air pressure to break the seal. Accordingly, various techniques have been used to position the seal-forming structure and maintain it in sealing relation with the appropriate portion of the face.

One technique is to use an adhesive. See, for example, U.S. patent application publication No. US 2010/0000534. However, the use of adhesives may be uncomfortable for some people.

Another technique is to use one or more straps and/or stabilizing the harness. Many such harnesses are subject to one or more of discomfort, bulk, discomfort, and use.

2.2.3.2 Respiratory Pressure Treatment (RPT) device

Respiratory Pressure Therapy (RPT) devices may be used alone or as part of a system to deliver one or more of the above-described treatments, for example, by operating the device to generate an air stream for delivery to an airway interface. The air flow may be pressurized. Examples of RPT devices include CPAP devices and ventilators.

Barometric pressure generators are known in the field of applications such as industrial scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more common air pressure generators, such as reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical treatment may have drawbacks with respect to one or more of the following: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.

An example of a special requirement for some RPT devices is noise.

Existing RPT devices (only one sample, 10cmH in CPAP mode using the test method specified in ISO 3744 ₂ O measurement) of noise output levels.

RPT device name	A-weighted sound pressure level dB (A)	Years (approximately)
			C series Tango ^TM	31.9	2007
C series Tango with humidifier ^TM	33.1	2007
			S8 Escape ^TM II	30.5	2005
With H4i ^TM S8 Escape of humidifier ^TM II	31.1	2005
			S9 AutoSet ^TM	26.5	2010
S9 AutoSet with H5i humidifier ^TM	28.6	2010

One known RPT device for treating sleep disordered breathing is the S9 sleep treatment system manufactured by ResMed Limited. Another example of an RPT device is a ventilator. ResMed stiller for respirators, such as adult and pediatric respirators ^TM A range of invasive and non-invasive non-dependent ventilation support may be provided to a range of patients to treat a variety of disorders such as, but not limited to, NMD, OHS and COPD.

ResMed Elisée ^TM 150 ventilator and ResMed VS III ^TM Ventilators can provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of a variety of conditions. These ventilators provide a volumetric ventilation mode and a pneumatic ventilation mode with either a single limb circuit or a dual limb circuit. RPT devices typically contain a pressure generator, such as a motor-driven blower or compressed gas reservoir, and are configured to supply a flow of air to the airway of a patient. In some cases, the flow of air may be provided to the airway of the patient at a positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

The designer of the device may present an unlimited number of choices that may be made. Design criteria often conflict, which means that some design choices are far from routine or unavoidable. Furthermore, certain aspects of comfort and efficacy may be highly sensitive to small and subtle changes in one or more parameters.

2.2.3.3 humidifier

Delivering the air flow without humidification may result in airway dryness. The use of a humidifier with an RPT device and patient interface generates humidified gases, minimizing nasal mucosa desiccation and increasing patient airway comfort. Furthermore, in colder climates, warm air, which is typically applied to the facial area in and around the patient interface, is more comfortable than cold air.

A range of manual humidification devices and systems are known, however they may not meet the specific requirements of medical humidifiers.

Medical humidifiers are used to increase the humidity and/or temperature of an air stream relative to ambient air when needed, typically at a point where the patient may be asleep or resting (e.g., at a hospital). Placed at the bedside may be a small medical humidifier. The medical humidifier may be configured to only humidify and/or heat the air flow delivered to the patient, without humidifying and/or heating the patient's surroundings. Room-based systems (e.g. saunas, air conditioners or evaporative coolers) may also humidify the air breathed by the patient, for example, however these systems also humidify and/or heat the whole room, which may cause discomfort to the occupants. Furthermore, medical humidifiers may have more stringent safety restrictions than industrial humidifiers

While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may not be sufficiently humidified, and some are difficult or inconvenient for the patient to use.

2.2.3.4 data management

There may be clinical reasons for obtaining data to determine whether a patient prescribed respiratory therapy has "complied with," e.g., the patient has used their RPT device according to one or more "compliance rules. One example of a compliance rule for CPAP therapy is that to achieve compliance, the patient is required to use the RPT device for at least four hours in at least 21 of the consecutive 30 days. To determine patient compliance, a provider of the RPT device (such as a healthcare provider) may manually obtain data describing the treatment of the patient using the RPT device, calculate usage over a predetermined period of time, and compare to compliance rules. Once the healthcare provider has determined that the patient has used their RPT device according to compliance rules, the healthcare provider may know that the third party patient is compliant.

Other aspects of patient treatment may exist that would benefit from communication of treatment data to a third party or external system.

Existing processes of communicating and managing such data can be one or more of expensive, time-consuming, and error-prone.

2.2.3.5 mandible reduction

Mandibular Reduction Device (MRD) or Mandibular Advancement Device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from dentists or other suppliers that holds the mandible (mandible) in a forward position during sleep. MRD is a removable device that patients insert into their mouth before sleeping and remove after sleeping. Thus, MRDs are not designed to be worn all the time. The MRD may be custom made or produced in standard form and include an bite impression designed to allow fitting into a patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, exerting tension on the pharyngeal wall to reduce collapse of the airway and reduce palate vibration.

In some examples, the mandibular advancement device may include an upper splint for engaging or fitting over teeth on the upper jaw or the maxilla and a lower splint for engaging or fitting over teeth on the upper jaw or the mandible. The upper clamping plate and the lower clamping plate are transversely connected together through a pair of connecting rods. A pair of connecting rods are symmetrically fixed on the upper clamping plate and the lower clamping plate.

In this design, the length of the link is selected so that the mandible remains in the advanced position when the MRD is placed in the patient's mouth. The length of the link can be adjusted to change the level of protrusion of the mandible. The dentist can determine the level of protrusion of the mandible, which will determine the length of the link.

Some MRDs are configured to push the mandible forward relative to the maxilla, while other MADs (such as ResMed Narval CCTMMRD) are designed to hold the mandible in a forward position. The device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. Thus, it is configured to minimize or prevent any movement of one or more teeth.

2.2.3.6 vent technology

Some forms of treatment systems may include an exhaust port to allow for the evacuation of exhaled carbon dioxide. The vent may allow gas to flow from an interior space of the patient interface, such as a plenum, to an exterior, such as an ambient environment, of the patient interface.

The vent may comprise an orifice and through which gas may flow in use of the mask. Many such vents are noisy. Others may clog during use, providing insufficient flushing. Some vents may interfere with sleep of the bed partner 1100 of the patient 1000, such as by noise or concentrated airflow.

A number of improved mask ventilation techniques have been developed by rismate limited. See International patent application publication No. WO 1998/034,665; international patent application publication No. WO 2000/078,381; U.S. Pat. nos. 6,581,594; U.S. patent application publication No. US 2009/0050156; U.S. patent application publication No. 2009/0044808.

Noise table of existing masks (ISO 17510-2:2007, 10cmH at 1 m) ₂ O pressure

Sample only, at 10cmH in CPAP mode using the test method specified in ISO 3744 ₂ O-under measurement

The sound pressure values of the various objects are listed below

2.2.4 screening, diagnostic and monitoring System

Polysomnography (PSG) is a conventional system for diagnosing and monitoring heart-lung disorders and typically involves a clinical specialist to apply the system. PSG typically involves placing 15 to 20 contact sensors on the patient to record various body signals, such as electroencephalograms (EEG), electrocardiography (ECG), electrooculography (EOG), electromyography (EMG), etc. PSG of sleep disordered breathing involves observing the patient in the clinic for two nights, the first night for pure diagnosis and the second night for the clinician to titrate the treatment parameters. Thus, PSG is expensive and inconvenient. In particular, it is not suitable for home screening/diagnosis/monitoring of sleep disordered breathing.

Screening and diagnosis generally describes identifying a condition from its signs and symptoms. Screening typically gives true/false results, indicating whether the patient's SDB is severe enough to warrant further investigation, whereas diagnosis may yield clinically actionable information. Screening and diagnosis tend to be a one-time process, while monitoring the progress of a pathology may continue indefinitely. Some screening/diagnostic systems are only suitable for screening/diagnosis, while some may also be used for monitoring.

Clinical professionals are able to adequately screen, diagnose, or monitor patients based on visual observations of PSG signals. However, there are situations in which a clinical expert may not be reached or may not be reached. Different clinical professionals may have different opinion on the pathology of a patient. Furthermore, a given clinical expert may apply different criteria at different times.

3 summary of the invention

The present technology relates to providing medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders with one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating, or preventing a respiratory disorder.

One aspect of certain forms of the present technology is to provide methods and/or devices that improve patient compliance with respiratory therapy.

One aspect of the present technology relates to a connector assembly for a patient interface that includes separately molded components to reduce restriction of material.

One aspect of the present technology relates to a connector assembly for a patient interface that includes a low profile button portion.

One aspect of the present technology relates to a patient interface for delivering a flow of air at positive pressure relative to ambient air pressure to an entrance to an airway of a patient while the patient is asleep to improve sleep disordered breathing. The patient interface includes: a seal-forming structure constructed and arranged to form a seal with a region of a patient's face surrounding an entrance to a patient's airway; a positioning and stabilizing structure that provides a force for maintaining the seal-forming structure in a therapeutically effective position on the patient's head; and a connector assembly adapted to be connected to an air circuit. The connector assembly includes a ring member configured to be removably and releasably secured in an aperture of an attachment region of a patient interface and an elbow assembly configured to connect to the air circuit. The elbow assembly is repeatedly attachable to and detachable from the ring member. The elbow assembly includes an elbow member and a clamp member. The clip member includes a separate and distinct structure from the elbow member, and the clip member is constructed and arranged to be connected to the elbow member. The clip member is configured and arranged to releasably connect the elbow assembly to the ring member, and the elbow member is configured and arranged to form a seal with the ring member when the elbow assembly and the ring member are connected to one another.

One aspect of certain forms of the present technology is an easy-to-use medical device, such as easy-to-use by a person who is not medically trained, by a person with limited dexterity, vision, or by a person with limited experience in using this type of medical device.

One aspect of one form of the present technology is a patient interface that can be cleaned in a patient's home, for example, in soapy water, without the need for specialized cleaning equipment.

Of course, some of these aspects may form sub-aspects of the present technology. Various aspects of the sub-aspects and/or aspects may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

Other features of the present technology will become apparent from the following detailed description, abstract, drawings, and claims.

Description of the drawings

The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings and in which like reference numerals refer to similar elements and in which:

4.1 treatment System

Fig. 1A illustrates a system that includes a patient 1000 wearing a patient interface 3000 in the manner of a nasal pillow receiving a supply of air under positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and flows along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient sleeps in a supine sleeping position.

Fig. 1B illustrates a system that includes a patient 1000 wearing a patient interface 3000 in the manner of a nasal mask receiving a supply of air under positive pressure from an RPT device 4000. Air from the RPT device is humidified in the humidifier 5000 and flows along the air circuit 4170 to the patient 1000.

Fig. 1C illustrates a system that includes a patient 1000 wearing a patient interface 3000 in a full-face mask receiving a supply of air under positive pressure from an RPT device 4000. Air from the RPT device is humidified in the humidifier 5000 and flows along the air circuit 4170 to the patient 1000. The patient sleeps in a side lying sleeping position.

4.2 respiratory System and facial anatomy

Figure 2A shows an overview of the human respiratory system including nasal and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lung, alveolar sacs, heart and diaphragm.

Fig. 2B shows a view of the upper airway of a human including the nasal cavity, nasal bone, extra-nasal cartilage, alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus and trachea.

Fig. 2C is a front view of a face with several surface anatomical features identified, including upper lip, upper lip red, lower lip, mouth width, inner canthus, nose wings, nasolabial folds, and corners of the mouth. Upper, lower, radially inward and radially outward directions are also shown.

Fig. 2D is a side view of a head with several surface anatomical features identified, including an inter-eyebrow, a nasal bridge point, a nasal protrusion point, a subnasal septum point, an upper lip, a lower lip, an upper chin point, a nasal ridge, a nasal wing apex, an upper ear base point, and a lower ear base point. The up-down and front-back directions are also indicated.

Fig. 2E is another side view of the head. The approximate locations of Frankfort's flat angle and nose lip angle are indicated. Coronal plane is also indicated.

Figure 2F illustrates a bottom view of a nose with several features identified, including the nasolabial folds, lower lips, upper lip reds, nostrils, subnasalium, columella, nasomentum dot, long axis of nostrils, and central sagittal plane.

Fig. 2G shows a side view of the surface features of the nose.

Fig. 2H shows subcutaneous structures of the nose, including lateral cartilage, septal cartilage, alar cartilage, seedlike cartilage, nasal bone, epidermis, adipose tissue, frontal processes of the maxilla, and fibrous adipose tissue.

Figure 2I shows the medial anatomic view of the nose, about a few millimeters from the central sagittal plane, showing, among other things, the medial foot of the septal cartilage and the alar cartilage of the nose.

Fig. 2J shows a front view of the skull, including the frontal, nasal and zygomatic bones. Turbinates, as well as maxilla and mandible, are also indicated.

Fig. 2K shows a side view of a skull with a head surface profile and several muscles. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone and occipital bone. The chin bulge is indicated. The following muscles are shown: two abdominal muscles, a bite muscle, a sternocleidomastoid muscle, and a trapezius muscle.

Fig. 2L is a front side view of the nose.

4.3 patient interface

Fig. 3A illustrates a patient interface in the form of a nasal mask in accordance with one form of the present technique.

Fig. 3B shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a positive sign and has a relatively large amplitude when compared to the amplitude of curvature illustrated in fig. 3C.

Fig. 3C shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a positive sign and has a relatively small amplitude when compared to the amplitude of curvature illustrated in fig. 3B.

Fig. 3D shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point is zero.

Fig. 3E shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a negative sign and a relatively small amplitude when compared to the amplitude of curvature illustrated in fig. 3F.

Fig. 3F shows a schematic view of a cross section through a structure at a point. The outward normal at this point is indicated. The curvature at this point has a negative sign and a relatively large amplitude when compared to the curvature amplitude illustrated in fig. 3E.

Fig. 3G shows a cushion for a mask comprising two pillows. Indicating the outer surface of the pad. Indicating the edges of the surface. The dome region and saddle region are indicated.

Fig. 3H shows a cushion for a mask. Indicating the outer surface of the pad. Indicating the edges of the surface. The path on the surface between points a and B is indicated. The straight line distance between point a and point B is indicated. Two saddle regions and one dome region are indicated.

Fig. 3I shows a surface with a one-dimensional pore structure on the surface. The planar curve illustrated forms the boundary of a one-dimensional hole.

Fig. 3J shows a cross section through the structure of fig. 3I. The illustrated surface defines a two-dimensional aperture in the structure of fig. 3I.

Fig. 3K shows a perspective view of the structure of fig. 3I, including two-dimensional holes and one-dimensional holes. The surface defining the two-dimensional aperture in the structure of fig. 3I is also shown.

Figure 3L shows a mask with an inflatable bladder as a cushion.

Fig. 3M shows a cross section through the mask of fig. 3L and illustrates the inner surface of the balloon. The inner surface defines a two-dimensional aperture in the mask.

Fig. 3N shows another cross-section through the mask of fig. 3L. The interior surfaces are also indicated.

Fig. 3O shows a left hand rule.

Fig. 3P shows the right hand rule.

Fig. 3Q illustrates the left ear, including the left ear spiral.

Fig. 3R illustrates the right ear, including the right ear spiral.

Fig. 3S shows a right-hand spiral.

Fig. 3T shows a view of the mask including a sign of torsion of the spatial curve defined by the edges of the sealing film in different regions of the mask.

Fig. 3U illustrates a view of the plenum chamber 3200, which illustrates the sagittal plane and the intermediate contact plane.

Fig. 3V shows a view of the rear of the plenum of fig. 3U. The direction of the view is perpendicular to the intermediate contact plane. The sagittal plane in fig. 3V bisects the plenum into left and right sides.

Fig. 3W shows a section through the plenum of fig. 3V, the section being taken at the sagittal plane shown in fig. 3V. The "middle contact" plane is shown. The intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of the chord 3210 that lies in the sagittal plane and contacts the cushion of the plenum at just two points (upper point 3220 and lower point 3230) on the sagittal plane. The intermediate contact plane may be tangential at the upper and lower points, depending on the geometry of the pad in this region.

Fig. 3X shows the plenum chamber 3200 of fig. 3U in a position for use on a face. When the plenum chamber is in the in-use position, the sagittal plane of the plenum chamber 3200 generally coincides with the mid-sagittal plane of the face. The intermediate contact plane generally corresponds to the plane of the 'face' when the plenum is in the in-use position. In fig. 3X, the plenum chamber 3200 is the plenum chamber of the nasal mask, and the upper point 3220 is located approximately on the root of the nose, while the lower point 3230 is located on the upper lip.

Fig. 4 is a perspective view of a patient interface shown on a patient's head in accordance with examples of the present technology.

Fig. 5 is a rear perspective view of an example connector assembly in accordance with the present technology.

Fig. 6 is a front perspective view of the connector assembly shown in fig. 5.

Fig. 7 is a rear view of the connector assembly shown in fig. 5.

Fig. 8 is a front view of the connector assembly shown in fig. 5.

Fig. 9 is a top view of the connector assembly shown in fig. 5.

Fig. 10 is a bottom view of the connector assembly shown in fig. 5.

Fig. 11 is a side view of the connector assembly shown in fig. 5.

Fig. 12 is a cross-sectional view of the connector assembly shown in fig. 11.

Fig. 13 is an enlarged portion of the cross section of fig. 12.

Fig. 14 is a cross-sectional view of the connector assembly shown in fig. 9.

Fig. 15 is an exploded view of the connector assembly shown in fig. 5.

Fig. 16 is a side view of the elbow assembly of the connector assembly shown in fig. 5.

Fig. 17 is a rear view of the elbow member shown in fig. 16.

Fig. 18 is a top view of the elbow member shown in fig. 16.

Fig. 19 is a bottom view of the clip member of the connector assembly shown in fig. 5.

Fig. 20 is an enlarged portion of the clip member shown in fig. 15.

Fig. 21 is a perspective view of a ring member of the connector assembly shown in fig. 5.

Fig. 22 is a side view of the ring member shown in fig. 21.

Fig. 23 is a perspective view of a patient interface including a connector assembly in accordance with examples of the present technique, wherein an elbow assembly is engaged with a ring member.

Fig. 24 is a perspective view of a patient interface including a connector assembly in accordance with examples of the present technique, with the elbow assembly disengaged from the ring member.

Fig. 25 is a cross-sectional view of a patient interface including a connector assembly in accordance with examples of the present technique, wherein an elbow assembly is engaged with a ring member.

Fig. 26 is a cross-sectional view of a patient interface including a connector assembly in accordance with examples of the present technique, wherein the elbow assembly is manually disengaged from the ring member.

Fig. 27 is a perspective view of an elbow member in accordance with another example of the present technique.

Fig. 28 is a top view of the elbow member shown in fig. 27.

Fig. 29 is a rear view of the elbow member shown in fig. 27.

Fig. 30 is a perspective view of the elbow member illustrated in fig. 27 with the clip member attached thereto.

FIG. 31 is a side view of an integral elbow member and clip member according to another example of the present technology.

5 detailed description of the preferred embodiments

Before the present technology is described in further detail, it is to be understood that this technology is not limited to particular examples described herein, as such may vary. It is also to be understood that the terminology used in the present disclosure is for the purpose of describing particular examples described herein only and is not intended to be limiting.

The following description is provided with respect to various examples that may share one or more common characteristics and/or features. It should be understood that one or more features of any example may be combined with one or more features of another example or other examples. In addition, in any of the examples, any single feature or combination of features may constitute further examples.

5.1 treatment

In one form, the present technique includes a method for treating a respiratory disorder that includes the step of applying positive pressure to an airway inlet of a patient 1000.

In some examples of the present technology, the air supply under positive pressure is provided to the nasal passages of the patient via one or both nostrils.

In some examples of the present technology, mouth breathing is restricted, or prevented.

5.2 treatment System

In one form, the present technology includes an apparatus or device for treating a respiratory disorder. The apparatus or device may include an RPT device 4000 for supplying pressurized air to the patient 1000 via an air circuit 4170 to a patient interface 3000, see for example fig. 1A-1C.

5.3 patient interface

Referring to fig. 3A, a non-invasive patient interface 3000 in accordance with one aspect of the present technique includes the following functional aspects: seal forming structure 3100, plenum chamber 3200, positioning and stabilizing structure 3300, vent 3400, one form of connection port 3600 for connection to air circuit 4170, and forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround an entrance to the patient's airway in order to supply positive pressure air to the airway.

If the patient interface is unable to comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

A patient interface 3000 in accordance with one form of the present technique is constructed and arranged to be capable of operating at least 6cmH relative to the environment ₂ The positive pressure of O provides air.

Patient interface 3000 in accordance with one form of the present technique is constructed and arranged to be capable of operating at least 10cmH relative to the environment ₂ The positive pressure of O provides air.

Patient interface 3000 in accordance with one form of the present technique is constructed and arranged to be capable of operating at least 20cmH relative to the environment ₂ The positive pressure of O provides air.

Fig. 4 illustrates a non-invasive patient interface 6000 in accordance with an aspect of the present technique. As shown, patient interface 6000 includes the following functional aspects: pad assembly 6150, positioning and stabilizing structure 6300, and connection port 6600 for connection to air circuit 4170. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects.

The pad assembly 6150 includes a seal forming structure 6100 and a plenum 6200. In use, the plenum 6200 receives a supply of positive pressure air from the air circuit 4170 and the seal-forming structure 6100 is arranged to seal with the region around the entrance to the patient's airway in order to supply positive pressure air to the airway.

In the form of the present technique illustrated in fig. 4, the positioning and stabilizing structure 6300 comprises two tubes 6350 (e.g., made of flexible silicone), the tubes 6350 delivering pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the airway of the patient, for example, through the plenum 6200 and seal forming structure 6100. Each tube 6350 is positioned in use on a different side of the patient's head and extends across a respective cheek region, above a respective ear (above the earbase on the patient's head) to a connection port 6600 on the patient's overhead.

The positioning and stabilizing structure 6300 may be referred to as a "headgear" because it engages the patient's head to maintain the patient interface 6000 in a sealed position. Tube 6350 is an integral part of headgear 6300 of patient interface 6000 to position and stabilize seal-forming structure 6100 of the patient interface to the appropriate portion of the patient's face (e.g., nose and/or mouth). This allows the conduit of the air circuit 4170 that provides the pressurized air flow to be connected to the connection port 6600 of the patient interface, for example, at a location other than the front of the patient's face.

In some forms of the present technique, patient interface 6000 may include connection ports 6600 located near the top, sides, or back of the patient's head. For example, in the form of the present technique shown in fig. 4, the connection port 6600 is located on top of the patient's head.

In the form of the technique illustrated in fig. 4, two tubes 6350 are fluidly connected to each other at their upper ends and to a connection port 6600. In one embodiment the two tubes are integrally formed, while in other embodiments the tubes are separate components that are connected together in use and can be disconnected, for example for cleaning or storage.

An intermediate conduit portion or attachment region 6352 (e.g., made of flexible silicone) is provided to fluidly connect the two tubes 6350 to each other at their upper ends. The intermediate conduit portion 6352 includes an opening or aperture connectable, in use, to the connection port 6600. The intermediate conduit portion 6352 may be integrally formed with the two tubes or may be in the form of a separate connector comprising ends, each of which may be fluidly connected to a respective tube 6350.

In one example, as illustrated for example in fig. 4, the positioning and stabilizing structure 6300 comprises a rear headgear strap 6310 connected between two tubes 6350 positioned on each side of the patient's head and passing around the back of the patient's head, such as covering or underlying the occiput of the patient's head in use.

In some forms of the present technology, the positioning and stabilizing structure 6300 includes an adjustment mechanism 6360 configured to allow adjustment of the dimensions of the positioning and stabilizing structure 6300. For example, patient interface 6000 illustrated in fig. 4 includes tubes 6350 that include telescoping tube portions 6362 between the lengths of tubes 6350.

Further examples and details of patient interface 6000 are described in PCT publication No. WO 2017/124155, the contents of which are incorporated herein by reference in their entirety.

It should be appreciated that aspects of the present technology may be adapted for use with other suitable interface arrangements and types, e.g., full face/oronasal interface, nasal prongs.

Connector assembly

Fig. 5-26 illustrate a connection port 7600 for a patient interface 6000 in accordance with another example of the present technique. Although the present technique is described with reference to patient interface 6000, it should be understood that the technique is not limited to such particular examples and may be adapted for use with other suitable interface arrangements and types.

In the example shown, the connection port 7600 is in the form of a connector assembly that is constructed and arranged to provide a releasable connection between the patient interface 6000 and the air circuit 4170.

The connector assembly 7600 includes an elbow assembly 7700 configured to connect to the air circuit 4170 (e.g., via a swivel connector 7790) and a ring member 7900 configured to connect to the patient interface 6000. As described in more detail below, the elbow assembly 7700 may be repeatedly engaged with and removably disengaged from (i.e., connectable to and disconnectable from) the ring member 7900 to facilitate a releasable or separable connection between the patient interface 6000 and the air circuit 4170.

Elbow assembly

The elbow assembly 7700 includes an elbow member 7710 having a first end 7712 and a second end 7714. In the example shown, the elbow member 7710 includes a 90 ° bend such that the first end 7712 is generally perpendicular to the second end 7714, i.e., the central axis of the first end 7712 is at a 90 ° angle to the central axis of the second end 7714. However, it should be understood that the first end 7712 and the second end 7714 may be arranged in alternative configurations, such as at non-perpendicular angles to each other.

The clip member 7730 is disposed on the first end 7712. In the example shown, the clip member 7730 is constructed and arranged to provide a releasable connection with the ring member 7900, such as a releasable snap-fit connection or a separable snap-fit connection assembly. The second end 7714 is provided with a swivel connector 7790 adapted to connect to the air circuit 4170 (e.g., a swivel connector 7790 permanently connected to the second end 7714).

Elbow pipe component

The first end 7712 of the elbow member 7710 includes a recess 7715 configured and arranged to receive the clip member 7730. Recess 7715 includes an upper recess 7715U that extends along an upper portion of elbow member 7710. The upper recess 7715U opens into a side recess 7715S extending along a respective side of the elbow member 7710. The depth of the recess 7715 is selected such that the clip member 7730 provides a low profile, e.g., portions of the clip member 7730 protrude only slightly beyond the outer surface of the recess 7715 surrounding the elbow member 7710.

Each side recess 7715S includes a tab 7716, which tab 7716 is configured and arranged to interact with the clamp arm 7740 of the clamp member 7730 to facilitate retention of the clamp member 7730 on the elbow member 7710 and manipulation of the clamp arm 7740.

The first end 7712 also includes a tubular end 7713, the tubular end 7713 configured to extend through the ring member 7900 and engage with a sealing member 7950 disposed on the ring member 7900 to provide a sealed gas flow path for delivering pressurized gas through the elbow assembly 7700 to the patient interface 6000.

The second end 7714 is provided with a swivel connector 7790. In one example, the swivel connector 7790 may be overmolded to the tubular end 7717 of the second end 7714 (see, e.g., fig. 14). As shown, the tubular end 7717 includes a channel 7717C to receive a radially inwardly extending protrusion 7795 provided to the swivel connector 7790 to axially retain the swivel connector 7790 on the second end 7714.

Further, a plurality of ventilation holes 7720 (e.g., at least 10 ventilation holes, e.g., 10 to 20 ventilation holes) are provided along the rear wall of the elbow member 7710 to allow exhaust gas to exit the patient interface 6000. The vent holes 7720 are arranged in columns as shown, however, it should be understood that the vent holes may be arranged in other suitable manners, such as concentrically. In one example, each vent hole 7720 may include a contour or taper along its length, e.g., each hole converging in the direction of exhaust. However, each vent 7720 may have other suitable shapes to direct exhaust or flushing gases. Further, in the example shown, the vent holes 7720 may be positioned on a portion of the generally planar or flat rear wall such that the outlet end of each vent hole is disposed along a generally planar or flat surface. However, it should be appreciated that the vent holes 7720 may be positioned on a portion of the elbow 7710 having other shapes, such as a circular or convex shape.

Clip member

The clamp member 7730 includes a pair of resilient, quick release clamp arms 7740 and a connecting portion 7760 that interconnects the clamp arms 7740 (i.e., clamp arms 7740) disposed at each end of the connecting portion 7760.

Each clamp arm 7740 includes a catch portion 7750 and a button or trigger portion 7780. The clamp arms 7740 are constructed and arranged to provide a releasable snap-fit connection or separable snap-fit connection assembly with the ring member 7900, e.g., a snap portion 7750 configured to deflect and snap into a recess or undercut on the ring member 7900. The button portion 7780 is constructed and arranged to be manually clamped or squeezed to deflect the catch portion 7750 for disengaging or releasing the catch portion 7750 from the ring member 7900 and thus allowing the elbow assembly 7700 to be disengaged from the ring member 7900.

Each catch 7750 includes a barbed end, rib, or catch 7755 configured to provide a snap-fit assembly with the loop member 7900. In the example shown, the catch 7755 includes a lead-in angle that facilitates push-assembly and a 90 return angle that resists or prevents pull-apart disassembly, e.g., the user must deflect the catch 7750 via the button 7780 to allow disassembly. Each button or trigger portion 7780 includes a finger grip 7781 (e.g., a depression) adjacent the free end of the clamp arm 7740. In addition, each catch 7750 has a recess 7757 on an inner surface to facilitate retention of the clamp member 7730 on the elbow member 7710 and manipulation of the clamp arm 7740.

Connection between a clip member and a bent tube member

In the example shown, the clip member 7730 and the elbow member 7710 comprise separately molded components (i.e., separate and distinct structures) that are then connected to each other, e.g., snap-fit connections. For example, the clip member 7730 may be constructed of a material that is more flexible than the material of the elbow member 7710, allowing the clip member 7730 to bend over the first end 7712 of the elbow member 7710 and connect to the first end 7712 of the elbow member 7710. In an example, a retaining arrangement is provided to connect or secure the clip member to the elbow member, e.g., a snap fit connection or snap-fit assembly.

In the example shown, the clip member 7730 includes an open-ended configuration having a semi-flexible and generally semi-circular connection 7760 that allows the clip member 7730 to be connected to, for example, the elbow member 7710 in a manner similar to a circlip.

For example, the connection portion 7760 of the clip member 7730 and the upper recess portion 7715U of the elbow member 7710 may be constructed and arranged to be at least partially aligned with each other along the assembly direction, and the connection portion 7760 is constructed and arranged to engage over the upper recess portion 7715U and fit into the upper recess portion 7715U, e.g., snap or clip in place, to securely and releasably interconnect the clip member 7730 and the elbow member 7710 in the assembled position. The connection 7760 is formed in a semi-circular or arcuate shape and has a sufficiently small cross-section that it is generally semi-flexible or bendable to enable the clip member 7730 to clip around and over the elbow member 7710.

The attachment portion 7760 of the clip member 7730 is constructed and arranged to provide one or more functions. For example, the connection 7760 provides a structure to attach the clip member 7730 to the elbow member 7710. The connection 7760 has a shape configured to fit into the upper recess 7715U of the elbow member 7710, and a structural rigidity sufficient to hold the clip member 7730 in place on the elbow member 7710. In one example, the clip member 7730 is flexible enough to allow removal, e.g., the clip member may not be so rigid that the clip member cannot be removed. However, in alternative examples, the clip member 7730 may be non-removably connected to the elbow member 7710, e.g., the clip member may be rigid such that the clip member cannot be removed. In examples where clip member 7730 is removable, the ability of connection 7760 to flex provides the ability of clip member 7730 to be removed. Similarly, the resistance of the connection 7760 to bending provides the ability to hold the clip member 7730 in place on the elbow member 7710.

In one example, the catch 7750 of the clip member 7730 can be biased inwardly such that when the clip member 7730 is connected to the elbow member 7710, the catch 7750 is biased inwardly to grip the elbow member 7710 and provide further resistance to removal from the elbow member 7710.

The catch 7750 also has features for retaining the clip member 7730 on the elbow member 7710. In particular, each of the clamp arms 7740 is constructed and arranged to fit into a respective one of the side recesses 7715S such that the recess 7757 on the inner surface of each catch 7750 is configured to receive a lug 7716 disposed in the respective side recess 7715S. Such a coupling arrangement (e.g., a snap-fit assembly) further retains the clip member 7730 on the elbow member 7710, i.e., the snap 7750 needs to deflect over the corresponding lugs 7716 to separate the clip member 7730 from the elbow member 7710. The resistance of the connection 7760 to bending provides resistance against such separation.

In the example shown, the elbow member 7710 and the clip member 7730 provide a two-part assembly or construction. An exemplary advantage of this two-part structure is that it may allow for fabrication with less material restrictions. For example, clip member 7730 and elbow member 7710 comprise separately molded components such that the interdependence between clip member 7730 and elbow member 7710 is less, e.g., clip member 7730 is not limited by the material of elbow member 7710. In one example, the clip member 7730 and the elbow member 7710 include different materials and/or different material properties relative to each other. In one example, the clip member 7730 and the elbow member 7710 are not molded from the same material as a single piece.

In one example, the elbow member 7710 may be constructed of a material (e.g., polycarbonate) that is more rigid than the material of the clip member 7730 (e.g., nylon-12). The material of the clamp member 7730 (e.g., nylon 12) may be relatively flexible and strong, e.g., to facilitate flexing of the clamp arms, resist wear, maintain connection to the elbow member. The material (e.g., polycarbonate) of the elbow member 7710 may be relatively rigid, e.g., wear resistant, clean to facilitate cleaning, and easy to manufacture.

Furthermore, the two-part construction may allow each part to be geometrically less complex, resulting in an assembly that may allow for a simpler tool for manufacturing.

In the example shown, the clip member 7730 is constructed and arranged to provide a releasable connection, such as a snap-fit connection, with the elbow member 7710. Such releasable or detachable arrangement may be advantageous in facilitating cleaning of the clamp member 7730 and the elbow member 7710 when detached.

In alternative examples, the clip member 7730 may be non-detachably connected to the elbow member 7710, e.g., the clip member may be permanently connected to the elbow member. Such a non-removable arrangement may be advantageous because it reduces the likelihood of the clip member being lost or broken. Because the clip member is external to the airflow path, thorough cleaning may not be necessary, for example, as compared to components exposed to the airflow path.

In one example, the clip member 7730 and the elbow member 7710 may comprise separately molded components that are then permanently connected to each other such that the clip member 7730 may not be separated from the elbow member 7710. Any suitable means may be employed to permanently join or connect the clip member and the elbow member.

In one example, the clip member 7730 and the elbow member 7710 may be welded or bonded to each other, such as by ultrasonic welding. For example, the clip member 7730 may be connected to the elbow member 7710 as described above, and then one or more portions (e.g., a central portion) of the connection portion 7760 of the clip member 7730 may be welded or bonded to the elbow member 7710 to permanently secure the clip member to the elbow member. This connection will enable the connection to provide sufficient torsion (and torsional resistance) to operate the clamp arm 7740.

Alternatively, the elbow assembly may be configured such that the clip member may be easily assembled to the elbow member, but the structure of the elbow member and/or the clip member makes disassembly difficult or challenging. Such an elbow assembly having separately manufactured elbow members and clip members may achieve desired advantages (e.g., less constraints on material selection) while avoiding additional welding or bonding operations to secure the clip members to the elbow members.

For example, as shown in fig. 27-30, the elbow member 7710 may include a tab or stop 7719 along the upper edge of each side recess 7715S. Each tab 7719 projects generally laterally outwardly from the bottom of the elbow member away from the corresponding side recess. When the clip member 7730 is connected to the elbow member 7710, the tabs or stops 7719 are arranged to make removal of the clip member from the elbow member more difficult. That is, the tabs or stops 7719 are arranged such that the clamping arms of the clamp member must be further offset from each other in order to clear the tabs or stops 7719 for separation.

As shown in fig. 30, when the clip member 7730 is connected to the elbow member 7710, the tabs 7719 protrude outwardly and over the sides of the clip member 7730 to provide resistance to removal or "deployment" of the clip member 7730 from the recess 7715 of the elbow member. The tab 7719 is located above the catch 7750 and rearward of the clip member connection 7760 (as seen in fig. 30), which positioning helps prevent the catch 7750 from being pushed upward and rearward.

The elbow assembly 7700 can also have a structure that helps prevent the catch 7750 from being pushed forward to remove the clip member 7730 from the elbow member 7710. In the example shown, the first end 7712 of the elbow member 7710 includes a radially outwardly extending ridge or flange 7722 that acts as a stop to prevent over-insertion of the elbow assembly 7700 into the ring member 7900, i.e., the flange 7722 abuts the ring member 7900 when the elbow assembly is fully inserted into the ring member 7900 (see, e.g., fig. 12). In one example, as illustrated in fig. 29, a portion of the flange 7722 may be wider (i.e., the widened portion extends further radially outward) to form a shelf 7723, such as along at least an edge of the upper recess 7715U of the elbow member 7710 adapted to receive the connection portion 7760 of the clip member 7730. The shelf 7723 may act as a stop to help prevent the connection 7760 and thus the entire clip member 7730 from being pushed forward out of the upper recess 7715U of the elbow member 7710.

Ring member

The ring member 7900 is configured to be removably and sealingly secured in an opening or aperture of the patient interface 6000, i.e., in an aperture 6355 of the intermediate conduit portion 6352 interconnecting the two tubes 6350 of the headgear 6300 (see fig. 23-26).

As best shown in fig. 22, when the ring member 7900 is secured in the aperture 6355, the ring member 7900 includes a first side 7910 adapted to be positioned in an inner side of the intermediate conduit portion 6352 and a second side 7920 adapted to be positioned in an outer side of the intermediate conduit portion 6352. The ring member 7900 includes a first flange 7915 on a first side 7910 and a second flange 7925 on a second side 7920. The first and second flanges 7915, 7925 define a headgear channel 7930 that sealingly engages the intermediate conduit portion 6352 of headgear 6300 when the ring member 7900 is secured in the aperture 6355, i.e., a circumferential surface of the channel 7930 is adapted to sealingly engage a lip 6354 defining the aperture 6355 in the intermediate conduit portion 6352 (see, e.g., fig. 25 and 26).

When the lip 6354 is engaged within the channel 7930, the ring member 7900 is secured in a substantially fixed position (i.e., the headband fits between the first flange 7915 and the second flange 7925 to help prevent the ring member 7900 from inadvertently separating from the headband) and is also unable to freely rotate due to surface friction. Moreover, this engagement prevents air from flowing through the aperture 6355 between the ring member 7900 and the intermediate conduit portion 6352. The ring member 7900 may be removed from the patient interface 6000 (e.g., for cleaning, inspection) by peeling the silicone material of the intermediate conduit portion 6352 from the ring member 7900.

The ring member 7900 further includes a clip flange 7940, the clip flange 7940 being configured and arranged to engage the clip member 7730 when the elbow assembly 7700 is releasably engaged with the ring member 7900. A second flange 7925 is disposed adjacent the clip flange 7940 such that the clip flange 7940 and the second flange 7925 define a clip channel 7945 for matingly receiving the catch 7755 of the clip member 7730. In the example shown, the clip flange 7940 provides an lead-in angle (e.g., a ramp or incline) in the assembly direction to facilitate pushing the elbow assembly 7700 onto the ring member 7900. The clip flange 7940 also provides a 90 ° return angle that resists or prevents pull-apart disassembly, e.g., the user must deflect the catch 7750 via the button 7780 to allow disassembly.

The ring member 7900 also includes a sealing member 7950 along its inner periphery adjacent the first side 7910. The sealing member 7950 is configured and arranged to provide a seal between the ring member 7900 and the elbow assembly 7700 when the elbow assembly 7700 is connected to the ring member 7900.

Releasable connection between elbow assembly and ring member

The elbow assembly 7700 is releasably connected to the ring member 7900 via a clamp arm 7740 (e.g., a snap fit or snap-fit assembly). In particular, the clip channel 7945 is configured to receive the rib or clip 7755 of each clip portion (e.g., the rib or clip is arranged to clip, grab, or hook the clip flange to provide a secure connection) to releasably retain the elbow assembly 7700 to the ring member 7900 and form a swivel connection, i.e., to allow the elbow assembly 7700 to freely rotate 360 ° about the axis of the ring member 7900 relative to the ring member 7900. That is, the ribs or snaps 7755 at the free end of each snap 7750 are configured to engage over and behind the clip flange 7940, such as by a snap fit, to releasably connect the elbow assembly 7700 to the ring member 7900 and prevent unintended disengagement.

The angled surface or ramp 7941 of the clamp flange 7940 in the assembly direction is configured to enable easier and smoother attachment of the elbow assembly 7700 to the ring member 7900. During attachment of the elbow assembly 7700 to the ring member 7900, the snaps 7750 and the snaps 7755 thereof must be forced to deflect or pivot radially outwardly to receive the snap flange 7940 after and upon engagement of the snap flange 7940 over the snap flange 7940 and twist each side of the connection 7760. Minimizing this force may improve ease of use of the elbow assembly. The angled surface 7941 of the clip flange 7940 and the lead-in angle of the catch 7755 enable a greater distance to be applied to the clip member, reducing the force required to deploy the catch and improving ease of use.

The button portion 7780 may be manually clamped or squeezed at an end opposite the respective catch 7755 to disengage the catch 7755 from the clamp flange 7940 on the ring member 7900.

Lugs 7716 within each side recess 7715S of the elbow member 7710 provide the function of a fulcrum and bottom stop. In the example shown, the lugs 7716 comprise a T-shape. The lateral portion of the T-shaped lugs 7716 serves as a fulcrum upon which the corresponding catch 7750 pivots. As described above, each catch 7750 pivots during engagement to receive the clip flange 7940 of the ring member 7900. In addition, each catch 7750 pivots during disengagement via a corresponding button portion 7780. Fig. 26 shows the clasp portion pivoted to disengage clasp 7755 from the clip flange 7940 on the ring member 7900 when the button portion 7780 is manually clamped or squeezed.

When the button portion is manually released, the leg of the T-shaped ledge 7716 acts as a stop to prevent the corresponding catch 7750 from bottoming out when pivoted to its operatively connected position. Alternatively, or in addition, a flange may be provided around the body of the elbow member, below the clip member, to act as a stop to limit movement of the catch.

Another function of the connection 7760 of the clip member 7730 is to provide resistance to pivoting of the catch 7750. As described above, the catch 7750 pivots to receive and release the clip flange 7940 of the ring member 7900. However, the catch preferably does not pivot without the user pressing the button portion, otherwise the clip member will not function to secure the elbow member to the ring member. The connecting portion of the clip member is connected to each catch substantially co-linear with the catch about its pivot point. The pivoting of the catch results in a torsion in the connection. Accordingly, the connecting portion 7760 is designed to have sufficient structural rigidity so as to have sufficient resistance to torsion so that the catching portion does not pivot unnecessarily. However, the connection portion must allow a certain amount of torsion in order to allow the pivoting of the clasp portion, thereby enabling the clasp to receive the clip flange of the ring member and release the clip flange from the ring member when the button portion is manually gripped or squeezed by a user.

Sealing between elbow assembly and ring member

The ring member 7900 includes a sealing member 7950, e.g., a flexible flange or radial lip seal, arranged to engage the elbow assembly 7700 to provide a seal for the airflow path when the elbow assembly 7700 is connected to the ring member 7900. In the illustrated example, the sealing mechanism is separate from the retention feature, e.g., the elbow member 7710 is adapted to form a seal with the ring member 7900, while the clip member 7730 is adapted to releasably connect the elbow assembly to the ring member 7900.

As shown in fig. 12 and 13, when the elbow assembly 7700 is inserted into the ring member 7900, the leading edge of the tubular end 7713 of the elbow member 7710 forms a face seal with the sealing member 7950, e.g., the leading edge of the tubular end 7713 deforms the sealing member 7950 to form a seal. This form of engagement minimizes surface area contact to reduce friction, allowing a seal to be formed between the components while allowing the elbow assembly to freely rotate relative to the ring member. When the sealing member is resilient, the sealing member resiliently returns to its original cantilevered position when the elbow assembly is removed from the ring member.

Further, the first end 7712 of the elbow member 7710 includes a radially outwardly extending ridge 7722 that acts as a stop to prevent over-insertion of the elbow assembly 7700 into the ring member 7900.

In the example shown, the seal slot 7905 is disposed to an inner perimeter or aperture of the ring member 7900 adjacent the first side, i.e., adjacent the first flange 7915 adapted to be located in the inner side of the intermediate conduit portion 6352 of the headgear 6300. The seal groove 7905 is arranged to receive the sealing member 7950 and secure the sealing member 7950 in an operative position (see, e.g., fig. 13).

In the illustrated example (see, e.g., fig. 13), the sealing member 7950 includes a generally L-shaped connection 7952 and a radial seal 7954 (e.g., a cylindrical, flexible flange, or radial lip seal) that protrudes radially inward from the connection 7952. As shown, the seal slot 7905 is generally L-shaped to receive the L-shaped connection 7952. In an example, the sealing member 7950 may be bonded or overmolded onto the ring member 7900.

In one example, as illustrated in fig. 13, a taper 7907 may be provided to the bore of the ring member 7900 adjacent to the recess 7905, e.g., the taper reduces the bore diameter from the seal groove to the major inner diameter of the bore. In one example, the taper 7907 may be configured and arranged to allow the radial seal 7954 of the seal member 7950 to protrude radially inward in a cantilevered fashion without minimal contact on either side of the radial seal.

Decoupling arrangement

The connector assembly 7600 provides decoupling of the air circuit 4170 from the patient interface, for example, to enhance decoupling of tube resistance on the patient interface to prevent seal instability.

A decoupled version is provided by the clamp arm 7740 which forms a swivel connection that allows the elbow assembly 7700 to freely rotate 360 ° relative to the ring member 7900. Another form of decoupling is provided by the swivel connector 7790, the swivel connector 7790 allowing the swivel connector 7790 (and the air circuit 4170 connected to the swivel connector 7790) to freely rotate 360 ° relative to the elbow member 7710.

The tubular end 7713 at the first end of the elbow member 7710 may be provided with a textured surface finish. Such a textured surface finish may help prevent screaming when the elbow member is rotated within the ring member in use. In addition, the textured surface finish may reduce the torque required to rotate the tube member within the ring member, i.e., smooth rotation. This arrangement reduces the force/torque applied to the headgear by the air circuit 4170 (tube drag), for example, as the patient moves.

The outer surface of the ring member 7900, particularly the outer surface that contacts the catch 7750 during assembly/disassembly of the elbow assembly and ring member, may also have a textured surface finish, for example, to reduce friction, thereby facilitating assembly/disassembly.

Low profile clip member

In the example shown, the clip member 7730 provides a low profile, e.g., the clip member is received in a recess of the elbow member such that one or more portions of the clip member are only slightly raised above an outer surface of the recess surrounding the elbow member.

For example, as shown in fig. 9, the clip member 7730 is received in the recess 7715 of the bent-tube-like member 7710 such that the button portion 7780 is located only slightly outside of the outer surface surrounding the recess 7715.

As described above, the catch 7750 is arranged to pivot on a corresponding lug 7716 on the elbow member 7710. The lugs 7716 are disposed within the respective side recesses 7715S of the elbow member 7710, and thus the overall length of the lugs extending outwardly from the elbow member (i.e., outwardly beyond the outer surface surrounding the side recesses) is shorter than if the lugs were disposed on the non-recessed surface of the elbow member. In addition, each snap 7750 includes a recess 7757 to receive a corresponding tab 7716, the tab 7716 further reducing the outward extent of the clip member 7730 when the clip member is connected to the elbow member 7710.

In one example, to form side recesses 7715S in elbow member 7710, the side walls of each side recess 7715S extend inwardly from the outer side walls of elbow member 7710 defining the outer surface, rather than cutting away the material of the side walls of the elbow member (i.e., thinning the outer side walls to form recesses). Fig. 8 shows the walls of side recess 7715S extending inwardly from the outer side wall of elbow member 7710 and into the flow path defined by elbow member 7710.

In one example, the side recesses 7715S and clip members 7730 are configured and arranged such that the outer surface of the button portion 7780 is not completely flush with the outer surface of the elbow member 7710, e.g., so as to provide a button portion 7780 that protrudes slightly for use by a patient (e.g., as illustrated in fig. 9).

In one example, the low profile button portion 7780 is less likely to catch on the hair of a patient and become tangled in use. The attachment portion 7760 of the clip member 7730 is also recessed within the upper recess 7715U (see, e.g., fig. 11) and is therefore less likely to become entangled in the patient's hair during use.

In one example, as shown in fig. 26, the side recesses 7715S may also act as "stops" to prevent the button portion 7780 from excessively moving or deflecting inward in use, thereby enhancing durability.

Alternative examples

It should be appreciated that aspects of the present technique may be adapted for use with other suitable connector arrangements.

For example, the connector assembly may not include an elbow at the air circuit connection to the patient interface. In alternative examples, aspects of the clip member may be applied to other connector arrangements, for example, aspects of the clip member may be applied to the end of an air circuit (short or long tube) that is coaxial with the connector.

In alternative examples, the connector assembly may be adapted for use with other suitable interface arrangements, such as full face mask systems, nasal mask systems. In the case of a full facepiece system, the connector assembly may comprise an AAV.

In the example shown, the elbow assembly contains a vent. In an alternative example, the elbow assembly may not contain a vent if a vent is provided elsewhere in the system.

In an alternative example, the clip member and the elbow member may be integrally formed as a single piece structure. For example, fig. 31 illustrates an example of an elbow assembly 8700 that includes an integral clip member 8730 and an elbow member 8710. In this example, the clasp of the clip member 8730 can be provided to a corresponding clasp portion 8750 as described above, and/or one or more clasps can be provided to a connection portion 8760 that connects the clasp portions.

5.3.1 seal formation Structure

In one form of the present technique, the seal forming structure 3100 provides a target seal forming region and may additionally provide a cushioning function. The target seal forming area is an area on the seal forming structure 3100 where sealing may occur. The area where the seal actually occurs-the actual sealing surface-may vary from day to day and from patient to patient within a given treatment session, depending on a number of factors including, for example, the location where the patient interface is placed on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100.

In some forms of the present technology, the seal-forming structure 3100 is constructed of a biocompatible material, such as silicone rubber.

The seal forming structure 3100 according to the present technology may be composed of a soft, flexible, resilient material such as silicone.

In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each configured to correspond to a different size and/or shape range. For example, the system may include one form of seal forming structure 3100 that is suitable for large sized heads but not small sized heads, and another suitable for small sized heads but not large sized heads.

5.3.1.1 sealing mechanism

In one form, the seal-forming structure includes a sealing flange that utilizes a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure in the interior of the plenum chamber 3200 acting on its underside, bringing it into tight sealing engagement with the face. The pressure assist mechanism may act in conjunction with elastic tension in the positioning and stabilizing structure.

In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange comprises a relatively thin member having a thickness of less than about 1mm, such as about 0.25mm to about 0.45mm, which extends around the perimeter of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and an edge of the plenum chamber 3200 and extends around at least a portion of the perimeter path. The support flange is or comprises a spring-like element and is adapted to support the sealing flange against buckling in use.

In one form, the seal forming structure may include a compression seal or a gasket seal. In use, the compression seal or gasket seal is constructed and arranged to be in compression, for example due to elastic tension in the positioning and stabilising structure.

In one form, the seal forming structure includes a tensioner. In use, the tensioning portion is held in tension, for example by adjacent regions of the sealing flange.

In one form, the seal-forming structure includes a region having an adhesive or cohesive surface.

In some forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted seal flange, a compression seal, a gasket seal, a tension, and a portion having an adhesive or bonding surface.

5.3.1.2 nasal bridge or nasal ridge regions

In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over a nasal or nasal bridge region or nasal ridge region of a patient's face in use.

In one form, the seal-forming structure includes a saddle region configured to form a seal over a nasal bridge region or nasal bridge region of a patient's face in use.

5.3.1.3 upper lip region

In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over an upper lip region (i.e., an upper lip) of a patient's face in use.

In one form, the seal-forming structure includes a saddle region configured to form a seal over an upper lip region of a patient's face in use.

5.3.1.4 chin area

In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over a chin area of a patient's face in use.

In one form, the seal-forming structure includes a saddle region configured to form a seal over a chin region of a patient's face in use.

5.3.1.5 forehead area

In one form, the seal-forming structure forms a seal over a forehead region of a patient's face in use. In this form, the plenum chamber may cover the eye in use.

5.3.1.6 nasal pillows

In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

A nasal pillow according to one aspect of the present technology includes: a frustoconical body having at least a portion thereof forming a seal on a bottom surface of the patient's nose; a handle; on the frustoconical floor and connecting the frustoconical to the flexible region of the stem. In addition, the nasal pillow attachment structure of the present technology includes a flexible region adjacent the base of the handle. The flexible regions may cooperate to facilitate a universal joint structure that is adaptable with relative movement of both displacement and angle between the frustoconical and nasal pillow connected structures. For example, the frustoconical position may be axially moved toward the stem-connecting structure.

5.3.2 plenum

The plenum chamber 3200 has a perimeter shaped to complement the surface contour of an average person's face in the area where the seal will be formed in use. In use, the edges of the plenum chamber 3200 are positioned immediately adjacent to the adjacent surface of the face. The seal forming structure 3100 provides the actual contact with the face. The seal forming structure 3100 may extend around the entire perimeter of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and seal forming structure 3100 are formed from a single piece of homogeneous material.

In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes in use. In other words, the eye is outside the pressurized volume defined by the plenum chamber. This form tends to be less obtrusive and/or more comfortable for the wearer, which may improve compliance with the treatment.

In some forms of the present technology, the plenum chamber 3200 is constructed of a transparent material, such as transparent polycarbonate. The use of a transparent material may reduce the prominence of the patient interface and help to improve compliance with the therapy. The use of transparent materials may help a clinician to see how the patient interface is positioned and functioning.

In some forms of the present technology, the plenum chamber 3200 is constructed of a transparent material. The use of translucent materials may reduce the prominence of the patient interface and help to improve compliance with the therapy.

5.3.3 positioning and stabilization Structure

The seal-forming structure 3100 of the patient interface 3000 of the present technology may be maintained in a sealed state by a positioning and stabilizing structure 3300 when in use.

In one form, the positioning and stabilizing structure 3300 provides a retention force that is at least sufficient to overcome the effect of positive pressure in the plenum chamber 3200 to lift off the face.

In one form, the positioning and stabilizing structure 3300 provides a retention force to overcome the effects of gravity on the patient interface 3000.

In one form, the positioning and stabilizing structure 3300 provides retention as a safety margin to overcome potential effects of damaging forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

In one form of the present technique, a positioning and stabilizing structure 3300 is provided that is configured in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the locating and stabilizing structure 3300 includes at least one strap that is rectangular in cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

In one form of the present technique, a positioning and stabilizing structure 3300 is provided that is configured to be less bulky and cumbersome to prevent a patient from lying in a supine sleeping position, with the back area of the patient's head on a pillow.

In one form of the present technique, a positioning and stabilizing structure 3300 is provided that is configured to be less bulky and cumbersome to prevent a patient from lying in a side sleep position, with a side region of the patient's head on a pillow.

In one form of the present technique, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between a front portion of the positioning and stabilizing structure 3300 and a rear portion of the positioning and stabilizing structure 3300. The decoupling portion is not resistant to compression and may be, for example, a flexible strap or a soft strap. The decoupling portion is constructed and arranged such that the presence of the decoupling portion prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal when the patient lays their head on the pillow.

In one form of the present technique, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the outer layer of fabric comprises loop material for engagement with the hook material portion.

In certain forms of the present technology, the positioning and stabilizing structure 3300 comprises a strap that is extendable, e.g., elastically extendable. For example, the strap may be configured to be in tension when in use and direct the force to bring the seal-forming structure into sealing contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

In one form of the present technique, the positioning and stabilizing structure includes a first strap constructed and arranged such that, in use, at least a portion of a lower edge of the first strap passes over an on-the-ear base of the patient's head and covers a portion of the parietal bone and not the occipital bone.

In one form of the present technology applicable to nasal only masks or to full face masks, the positioning and stabilizing structure includes a second strap constructed and arranged such that, in use, at least a portion of the upper edge of the second strap passes under the sub-aural base of the patient's head and covers or is located under the occiput of the patient's head.

In one form of the present technology applicable to nasal only masks or to full face masks, the positioning and stabilizing structure includes a third strap constructed and arranged to interconnect the first strap and the second strap to reduce the tendency of the first strap and the second strap to separate from each other.

In some forms of the present technology, the positioning and stabilizing structure 3300 includes a strap that is flexible and, for example, non-rigid. This aspect has the advantage that the belt makes it more comfortable for the patient to lie on while sleeping.

In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a strap configured to be breathable to allow moisture to be transported through the strap.

In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide a retention force to correspond to a different range of sizes and/or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large-sized heads, but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads, but not for large-sized heads.

5.3.4 vents

In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for flushing of exhaled gases, such as carbon dioxide.

In some forms, the vent 3400 is configured to allow continuous venting flow from the interior of the plenum chamber 3200 to the ambient environment while the pressure within the plenum chamber is positive relative to the ambient environment. The vent 3400 is configured such that the vent flow has a magnitude sufficient to reduce re-breathing of exhaled CO2 by the patient while maintaining therapeutic pressure in the plenum in use.

One form of vent 3400 in accordance with the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

The vent 3400 may be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure (e.g., a swivel).

5.3.5 decoupling structure

In one form, patient interface 3000 includes at least one decoupling structure, such as a spindle or ball and socket.

5.3.6 connection port

Connection port 3600 allows connection to air circuit 4170.

5.3.7 forehead support

In one form, patient interface 3000 includes forehead support 3700.

5.3.8 anti-asphyxia valve

In one form, the patient interface 3000 includes an anti-asphyxia valve.

5.3.9 port

In one form of the present technique, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows for direct measurement of a property of the gas within the plenum chamber 3200, such as pressure.

5.4 glossary of terms

For purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of the present technology. In other forms of the present technology, alternative definitions may be applied.

5.4.1 general concepts

Air: in certain forms of the present technology, air may be considered to refer to atmospheric air, and in other forms of the present technology, air may be considered to refer to some other combination of breathable gases, such as atmospheric air enriched with oxygen.

Environment: in certain forms of the present technology, the term "environment" refers to (i) being external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

For example, with respect to the environment of a humidifierHumidity of the waterMay be the humidity of the air immediately surrounding the humidifier, such as the humidity in a room in which the patient is sleeping. Such ambient humidity may be different from the humidity outside the room in which the patient is sleeping.

In another example, the ambient pressure may be pressure directly around the body or outside the body.

In some forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room in which the patient is located, in addition to noise generated by, for example, an RPT device or from a mask or patient interface. Ambient noise may be generated by sources outside the room.

Automatic Positive Airway Pressure (APAP) therapy: CPAP treatment, in which the treatment pressure is automatically adjustable, e.g., from breath to breath, between minimum and maximum, depending on the presence or absence of an indication of an SDB event.

Continuous Positive Airway Pressure (CPAP) treatment: respiratory pressure therapy, wherein the therapeutic pressure is substantially constant over the respiratory cycle of the patient. In some forms, the pressure at the entrance to the airway will be slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction, and decreasing in the absence of an indication of partial upper airway obstruction.

Flow rate: the volume (or mass) of air delivered per unit time. Flow may refer to an instantaneous quantity. In some cases, the reference to flow will be a reference to a scalar, i.e., an amount having only a size. In other cases, the reference to flow will be a reference to a vector, i.e., a quantity having both magnitude and direction. The flow rate may be represented by the symbol Q. The "flow rate" is sometimes reduced to a simple "flow" or "air stream".

In an example of patient breathing, the flow may be nominally positive for the inspiratory portion of the patient's breathing cycle and thus negative for the expiratory portion of the patient's breathing cycle. The total flow Qt is the air flow leaving the RPT device. The ventilation flow Qv is the air flow leaving the ventilation port to allow flushing of the exhaled air. Leakage flow rate Ql is leakage flow rate from the patient interface system or elsewhere. The respiratory flow Qr is the flow of air admitted into the respiratory system of the patient.

A humidifier: the term humidifier will be considered to refer to a humidification device constructed and arranged or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H) to an air stream ₂ O) vapor to improve the patient's medical respiratory condition.

Leakage: the word "leakage" will be considered as an unintended air flow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in a swivel elbow to the surrounding environment.

Noise, conductive (acoustic): conduction noise in this document refers to noise that is carried to the patient through pneumatic paths such as the air circuit and patient interface and air therein. In one form, the conducted noise may be quantified by measuring the sound pressure level at the end of the air circuit.

Noise, radiation (acoustic): radiation noise in this document refers to noise carried by ambient air to a patient. In one form, the radiated noise may be quantified by measuring the acoustic power/pressure level of the object in question according to ISO 3744.

Noise, aerated (acoustic): ventilation noise in this document refers to noise generated by air flow through any vent, such as a vent hole of a patient interface.

Patient: a person, whether or not they have a respiratory disorder.

Pressure: force per unit area. The pressure can be expressed in units of a range including cmH ₂ O、g-f/cm ² And hPa. 1cmH ₂ O is equal to 1g-f/cm ² 2, about 0.98 hPa. In the present specification, unless otherwise indicated, pressure is in cmH ₂ O is given in units.

The pressure in the patient interface is given the symbol Pm, while the therapeutic pressure, which represents the target value reached by the mask pressure Pm at the current moment, is given the symbol Pt.

Respiratory Pressure Therapy (RPT): an air supply is applied to the inlet of the airway at a process pressure that is generally positive relative to the atmosphere.

Breathing machine: mechanical means for providing pressure support to the patient to perform some or all of the respiratory effort.

5.4.1.1 material

Silicone or silicone elastomer: synthetic rubber. In the present specification, reference to silicone refers to Liquid Silicone Rubber (LSR) or Compression Molded Silicone Rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning corporation (Dow Corning). Another manufacturer of LSR is the Wacker group (Wacker). Unless specified to the contrary, exemplary forms of LSR have a shore a (or type a) indentation hardness ranging from about 35 to about 45 as measured using ASTM D2240.

Polycarbonate: is a transparent thermoplastic polymer of bisphenol A carbonate.

5.4.1.2 mechanical Properties

Rebound resilience: the ability of a material to absorb energy when elastically deformed and release energy when unloaded.

Elasticity: substantially all of the energy will be released upon unloading. Including, for example, certain silicones and thermoplastic elastomers.

Hardness: the ability of the material itself to resist deformation (e.g., described by young's modulus or indentation hardness scale measured on a standardized sample size).

The "soft" material may comprise silicone or thermoplastic elastomer (TPE) and may be easily deformed, for example, under finger pressure.

The "hard" material may comprise polycarbonate, polypropylene, steel or aluminum, and may not readily deform, for example, under finger pressure.

Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load may be a force or moment, such as compression, tension, bending or torsion. The structure or component may provide different resistances in different directions.

Flexible structures or components: when allowed to support its own weight for a relatively short period of time, for example, within 1 second, the structure or component will change shape (e.g., bend).

Rigid structures or components: a structure or component that does not substantially change shape when subjected to loads typically encountered in use. Examples of such use may be, for example, at about 20 to 30cmH ₂ The patient interface is disposed and maintained in sealing relationship with the entrance to the patient airway under the pressure of O.

As an example, the I-beam may contain a different bending stiffness (resistance to bending loads) in the first direction than in the second orthogonal direction. In another example, the structure or component may be flexible in a first direction and rigid in a second direction.

5.4.2 respiratory cycle

Apnea: according to some definitions, an apnea is considered to occur when the airflow is below a predetermined threshold for a period of time, for example 10 seconds. Obstructive apneas will be considered to occur when some obstruction of the airway does not allow air flow despite patient effort. Central apneas are considered to occur when an apnea is detected due to a reduction in respiratory effort or the absence of respiratory effort, although the airway is open (patent). Mixed apneas are considered to occur when a reduction in respiratory effort or the absence of an airway obstruction occurs simultaneously.

Respiratory rate: the rate of spontaneous breathing of a patient is typically measured in breaths per minute.

Duty cycle: ratio of inhalation time Ti to total breath time Ttot.

Effort (respiration): this is the work done by spontaneously breathing people attempting to breathe.

Expiratory portion of the respiratory cycle: a time period from the start of the expiratory flow to the start of the inspiratory flow.

Flow restriction: flow restriction will be considered an event state in the patient's breath where an increase in patient effort does not cause a corresponding increase in flow. Where flow restriction occurs during the inspiratory portion of the respiratory cycle, it may be described as inspiratory flow restriction. Where the flow restriction occurs during the expiratory portion of the respiratory cycle, it may be described as an expiratory flow restriction.

Flow limited inspiratory waveform type:

(i) Flattening: with an ascending portion followed by a relatively flat portion followed by a descending portion.

(ii) M shape: with two local peaks, one at the leading edge, one at the trailing edge, and a relatively flat portion between the two peaks.

(iii) Chair shape: there is a single local peak at the leading edge followed by a relatively flat portion.

(iv) Inverted chair type: with a relatively flat portion followed by a single local peak at the trailing edge.

Hypopnea: according to some definitions, hypopnea is considered to be a decrease in flow, rather than a cessation of flow. In one form, when the flow rate is below a threshold rate for a period of time, it can be said that hypopnea has occurred. When a hypopnea due to a reduced respiratory effort is detected, a central hypopnea will be considered to have occurred. In one form of adult, any of the following may be considered hypopneas:

(i) Patient respiration decreases by 30% for at least 10 seconds plus the associated 4% desaturation; or (b)

(ii) The patient's respiration is reduced (but less than 50%) for at least 10 seconds with at least 3% associated desaturation or arousal.

Hyperrespiration: the flow increases above normal.

Inhalation part of the respiratory cycle: the period from the start of inspiration flow to the start of expiration flow will be considered the inspiratory portion of the respiratory cycle.

Patency (airway): the degree of airway opening, or the extent of airway opening. The patient's airway is open. Airway patency may be quantified, for example, with a value of one (1) being patency and a value of 0 being closed (occluded).

Positive End Expiratory Pressure (PEEP): the pressure above the atmosphere present in the lungs at the end of exhalation.

Peak flow rate (Qpeak): the maximum value of the flow rate during the inspiratory portion of the respiratory flow waveform.

Respiratory flow rate, patient flow rate, respiratory flow rate (Qr): these terms may be understood to refer to an estimate of the respiratory flow rate of the RPT device, as opposed to a "true respiratory flow rate" or "true respiratory flow rate," which is the actual respiratory flow rate experienced by a patient, typically expressed in liters/minute.

Tidal volume (Vt): when no additional effort is applied, the volume of air inhaled or exhaled during normal breathing. In principle, the inspiratory volume Vi (the volume of inhaled air) is equal to the expiratory volume Ve (the volume of exhaled air), so a single tidal volume Vt can be defined as being equal to either amount. In practice, the tidal volume Vt is estimated as some combination, e.g., average, of the inhalation and exhalation amounts Vi, ve.

(inspiration) time (Ti): the duration of the inspiratory portion of the respiratory flow rate waveform.

(expiration) time (Te): the duration of the expiratory portion of the respiratory flow rate waveform.

(total) time (Ttot): the total duration between the beginning of one inspiratory portion of one respiratory flow rate waveform and the beginning of the next inspiratory portion of the respiratory flow rate waveform.

Typical recent ventilation: the recent value of ventilation Vent over some predetermined time scale tends to be a measure of the ventilation value gathered therearound, i.e., the central tendency of the recent value of ventilation.

Upper Airway Obstruction (UAO): including partial and total upper airway obstruction. This may be associated with a flow restriction state in which the flow rate increases only slightly, or may even decrease as the pressure differential across the upper airway increases (Starling resistor behavior).

Ventilation (vent): a measure of the rate at which the patient's respiratory system exchanges gas. The ventilation may include one or both of inhalation flow and exhalation flow per unit time. When expressed as a volume per minute, this amount is commonly referred to as "ventilation per minute". Ventilation per minute is sometimes expressed simply as volume, understood as volume per minute.

5.4.3 aeration

Adaptive Servo Ventilator (ASV): a servo-ventilator having a variable, rather than fixed, target ventilation. The variable target ventilation may be learned from some characteristic of the patient (e.g., the respiratory characteristics of the patient).

Backup frequency: if not triggered by spontaneous respiratory effort, a ventilator parameter is determined for a minimum respiratory rate (typically expressed in breaths per minute) that the ventilator will deliver to the patient.

And (3) circulation: the ventilator inhalation phase is terminated. When a ventilator delivers breath to a spontaneously breathing patient, at the end of the inspiratory portion of the respiratory cycle, the ventilator is said to circulate to stop delivering breath.

Positive expiratory airway pressure (EPAP): the base pressure, to which the pressure that varies in the breath is increased to produce the desired mask pressure that the ventilator will attempt to reach at a given time.

End-tidal pressure (EEP): the ventilator will attempt to achieve the desired mask pressure at the end of the exhale portion of the breath. If the pressure waveform template, pi (Φ), is zero at the end of expiration, i.e., pi (Φ) =0, where Φ=1, then EEP is equal to EPAP.

Inspiratory Positive Airway Pressure (IPAP): the ventilator attempts to reach the maximum desired mask pressure during the inspiratory portion of the breath.

Pressure support: a number indicating that the pressure increase during inspiration of the ventilator exceeds the pressure increase during expiration of the ventilator and generally means the pressure difference between the maximum value during inspiration and the base pressure (e.g., ps=ipap-EPAP). In some cases, pressure support means the difference that the ventilator wants to achieve, not the actual one.

Servo ventilator: a ventilator that measures patient ventilation has a target ventilation and adjusts the pressure support level to bring the patient ventilation to the target ventilation.

Spontaneous/timing (S/T): an attempt is made to detect the pattern of ventilators or other devices that spontaneously breathe the beginning of a patient's breath. However, if the device is unable to detect a breath within a predetermined period of time, the device will automatically initiate delivery of the breath.

Swinging: equivalent terms to pressure support.

Triggering: when a ventilator delivers breathing air to a spontaneously breathing patient, it is said to be triggered by the patient's effort to do so at the beginning of the breathing portion of the respiratory cycle.

5.4.4 anatomies

5.4.4.1 facial anatomy

Nose wings: the outer walls or "wings" of each naris (plural: alar)

Nose wing angle:

nose wing end: the outermost points on the nose wings.

Nose wing bending (or nose wing top) point: the last point in the curved baseline of each alar is found in the folds formed by the combination of the alar and cheek.

Auricle: the entire outer visible portion of the ear.

(nasal) skeleton: the nasal bone frame comprises nasal bone, frontal process of upper jaw bone and nose of frontal bone.

(nasal) cartilage scaffold: the nasal cartilage frame includes septum, lateral side, large and small cartilage.

Nose post: skin strips separating the nostrils and extending from the nasal projection to the upper lip.

Nose columella angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort (Frankfort) plane (with both lines intersecting at the subnasal septum point).

Frankfurt level: a line extending from the lowest point of the orbital rim to the left cochlea. The cochlea is the deepest point in the notch in the upper part of the tragus of the auricle.

Intereyebrow: is located on the soft tissue, the most prominent point in the mid-forehead sagittal plane.

Cartilage: a substantially triangular cartilage plate. The upper edge is attached to the nasal bone and the frontal process of the maxilla, and the lower edge is connected to the alar cartilage.

Lip, lower (lower lip):

lip, upper (upper lip):

nasal alar cartilage: a cartilage plate located under the extranasal cartilage. It curves around the anterior portion of the nostril. The posterior end of which is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four small cartilages of the nasal wings.

Nostrils (Nostrils): forming a generally oval aperture leading to the entrance to the nasal cavity. The singular form of a Nostril is the Nostril (Nostril norstral). The nostrils are separated by the nasal septum.

Nasolabial folds or folds: the nose extends from each side of the nose to the skin folds or furrows at the corners of the mouth, which separates the cheeks from the upper lip.

Nose lip angle: the angle between the post and the upper lip, while intersecting below the nasal side.

Lower ear base: the auricle adheres to the lowest point of the facial skin.

Upper ear base: auricles adhere to the highest point of facial skin.

Nose point: the most protruding point or tip of the nose, which can be identified in a side view of the rest of the head.

In humans: a midline groove extending from the lower boundary of the nasal septum to the top of the lip in the upper lip region.

Anterior chin point: is located at the anterior most midpoint of the chin above the soft tissue.

Ridge (nose): the nasal ridge is a midline projection of the nose that extends from the nasal bridge point to the nasal projection point.

Sagittal plane: a vertical plane from front (front) to back (rear). The mid-sagittal plane is the sagittal plane that divides the body into right and left halves.

Nose bridge point: is positioned on the soft tissue and covers the most concave point of the frontal nasal suture area.

Septal cartilage (nose): the septum cartilage forms part of the septum and separates the anterior portion of the nasal cavity.

Rear upper side sheet: at the point at the lower edge of the base of the nose, where the base of the nose engages the skin of the upper (superior) lip.

Subnasal point: is positioned on the soft tissue, and the point where the columella nasi meets the upper lip in the median sagittal plane.

Nasal ridge: the point of maximum concavity between the midline of the lower lip and the soft tissue bulge.

5.4.4.2 anatomy of the skull

Frontal bone: frontal bone includes a large vertical portion (frontal scale), which corresponds to an area called the forehead.

Mandible: the mandible forms the mandible. The geniog is the bone bulge of the mandible forming the chin.

Maxilla: the maxilla forms the upper jaw and is located above the lower jaw and below the orbit. The maxillary frontal process protrudes upward from the side of the nose and forms part of the lateral border.

Nasal bone: the nasal bone is two small rectangular bones, and the size and the shape of the nasal bone are different in different individuals; they are placed side by side in the middle and upper parts of the face and form the "beams" of the nose by their junctions.

Root of nose: the intersection of the frontal bone and the two nasal bones is located directly between the eyes and in the concave region above the bridge of the nose.

Occipital bone: occiput is located at the back and lower part of the skull. It includes oval holes (occipital macropores) through which the cranial cavity communicates with the spinal canal. The curved plate behind the occipital macropores is occipital scale.

Orbit of eye: a bone cavity in the skull that accommodates the eyeball.

Parietal bone: the parietal bone is the bone that when joined together forms the top cap and both sides of the skull.

Temporal bone: temporal bones are located at the base and sides of the skull and support the portion of the face called the temple.

Cheekbones: the face includes two cheekbones that are located on the top and sides of the face and form the protrusions of the cheeks.

5.4.4.3 respiratory anatomy

A diaphragm: muscle pieces extending across the bottom of the rib cage. The diaphragm separates the chest cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the chest cavity increases and air is drawn into the lungs.

Throat: the larynx or speaker houses the vocal cords and connects the lower part of the pharynx (hypopharynx) with the trachea.

Lung: the respiratory organs of humans. The conduction band of the lung contains the trachea, bronchi, bronchioles and terminal bronchioles. The respiratory tract comprises the respiratory bronchioles, alveolar ducts and alveoli.

Nasal cavity: the nasal cavity (or fossa of the nose) is a large air-filled space above and behind the middle of the face. The nasal cavity is divided into two parts by vertical fins called nasal septum. On the sides of the nasal cavity are three horizontal outward extensions known as turbinates (the single "outer ear") or turbinates. The front of the nasal cavity is the nose, while the rear is mixed into the nasopharynx via the nostrils.

Pharynx: is located immediately below the nasal cavity and in a portion of the throat above the esophagus and larynx. The pharynx is conventionally divided into three sections: nasopharynx (upper pharynx) (nasal part of pharynx), oropharynx (middle pharynx) (oral part of pharynx), laryngopharynx (lower pharynx).

5.4.5 patient interface

Anti-asphyxia valve (AAV): by opening to the atmosphere in a fail-safe manner, patient excess CO is reduced ₂ Components or sub-components of the mask system that are at risk of rebreathing.

Bending pipe: an elbow is an example of a structure that directs the axis of an air stream traveling therethrough to change direction through an angle. In one form, the angle may be about 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have an approximately circular cross-section. In another form, the elbow may have an oval or rectangular cross-section. In some forms, the elbow may be rotatable relative to the mating component, for example about 360 degrees. In some forms, the elbow may be removable from the mating component, for example, via a snap-fit connection. In some forms, the elbow may be assembled to the mating component via a single snap during manufacture, but not removable by the patient.

A frame: a frame will be considered to mean a mask structure that carries the tension load between two or more connection points with the headgear. The mask frame may be a non-hermetic carrier structure in the mask. However, some forms of mask frames may also be airtight.

Functional dead space:

a headband: the headband will be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, the headgear may include a set of one or more support rods, straps, and reinforcements configured to position and maintain the patient interface in a position on the patient's face for delivering respiratory therapy. Some laces are formed from a laminate composite of soft, flexible, elastic materials, such as foam and fabric.

Film: a film will be considered to mean a typically thin element that is preferably substantially free of bending resistance but stretch resistant.

A plenum chamber: the mask plenum chamber will be considered to mean that portion of the patient interface having a wall at least partially surrounding a volume of space that, in use, has air pressurized therein to above atmospheric pressure. The shell may form part of the wall of the mask plenum chamber.

And (3) sealing: may refer to the noun form of the structure (seal) or the verb form of the effect (seal). The two elements may be constructed and/or arranged to 'seal' or to achieve a 'seal' therebetween without the need for a separate 'seal' element itself.

A shell: the housing will be considered to mean a curved and relatively thin structure having a bendable, stretchable and compressible stiffness. For example, the curved structural wall of the mask may be the shell. In some forms, the housing may be faceted. In some forms, the housing may be airtight. In some forms, the housing may not be airtight.

Reinforcement: a reinforcement will be considered to mean a structural component designed to increase the bending resistance of another component in at least one direction.

And (3) supporting: the support will be considered as a structural component designed to increase the resistance to compression of another component in at least one direction.

In one form, the spin shaft may be configured to rotate through an angle of at least 360 degrees.

Lacing (a term: a structure for resisting tension).

Vent port: (noun): allowing air flow from the mask interior or conduit to ambient air, such as for efficient flushing of exhaled air. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on mask design and treatment pressure.

5.4.6 shape of the Structure

Products according to the present technology may include one or more three-dimensional mechanical structures, such as mask cushions or propellers. The three-dimensional structure may be defined by a two-dimensional surface. These surfaces may be distinguished using indicia to describe the associated surface orientation, position, function, or some other characteristic. For example, the structure may include one or more of a front surface, a back surface, an inner surface, and an outer surface. In another example, the seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., underside or inner) surface. In another example, a structure may include a first surface and a second surface.

To assist in describing the three-dimensional structure and shape of the surface, consider first a cross-section through a point p of the structure surface, see fig. 3B-3F, which illustrate the cross-section at the point p on the surface and the resulting planar curve examples. Fig. 3B to 3F also show the outward normal vector at p. The outward normal vector at p points away from the surface. In some examples, a surface from an imagined small person's point of view standing on the surface is described.

5.4.6.1 curvature in one dimension

The curvature of a planar curve at p may be described as having a sign (e.g., positive, negative) and a number (e.g., only the inverse of the radius of a circle contacting the curve at p).

Positive curvature: if the curve at p turns to the outward normal, the curvature at that point will be positive (if an imagined small person leaves the point p, they must walk uphill). See fig. 3B (relatively large positive curvature compared to fig. 3C) and fig. 3C (relatively small positive curvature compared to fig. 3B). Such a curve is commonly referred to as a concave surface.

Zero curvature: if the curve at p is a straight line, the curvature will be taken to be zero (if an imagined small person leaves the point p, they can walk horizontally without going up or down). See fig. 3D.

Negative curvature: if the curve at p turns away from the outward normal, the curvature in that direction at that point will be negative (if an imagined small person leaves the point p, they must walk down a slope). See fig. 3E (relatively small negative curvature compared to fig. 3F) and fig. 3F (relatively large negative curvature compared to fig. 3E). Such a curve is often referred to as convex.

Curvature of 5.4.6.2 two-dimensional surface

The description of the shape at a given point on a two-dimensional surface according to the present technique may include a plurality of normal cross-sections. The plurality of cross-sections may cut the surface in a plane comprising an outward normal ("normal plane"), and each cross-section may be taken in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at this point may have the same sign or different signs. Each curvature at this point has a number, e.g., a relatively small number. The planar curves in fig. 3B-3F may be examples of such multiple cross-sections at particular points.

Principal curvature and principal direction: the direction of the normal plane in which the curvature of the curve takes its maximum and minimum values is called the principal direction. In the examples of fig. 3B to 3F, the maximum curvature occurs in fig. 3B and the minimum value occurs in fig. 3F, so fig. 3B and 3F are cross sections in the main direction. The principal curvature at p is the curvature in the principal direction.

Area of the surface: a connected set of points on the surface. The set of points in the region may have similar characteristics, such as curvature or sign.

Saddle region: where at each point the principal curvatures have opposite signs, i.e. one sign is positive and the other sign is negative (they can walk up or down depending on the direction in which the imagined individual is turning).

Dome area: where the principal curvature has the same sign at each point, for example two regions of positive ("concave dome") or two negative ("convex dome").

Cylindrical region: where one principal curvature is zero (or zero within manufacturing tolerances, for example) and the other principal curvature is non-zero.

Planar area: a surface area where both principal curvatures are zero (or zero within manufacturing tolerances, for example).

Surface edge: boundary or demarcation of a surface or area.

Path: in some forms of the present technology, 'path' will be considered to mean a path in a mathematical-topological sense, such as a continuous space curve from f (0) to f (1) on a surface. In some forms of the present technology, a 'path' may be described as a route or process, including, for example, a set of points on a surface. (the imaginary path of an individual is a path in which they walk on a surface and resemble a garden path).

Path length: in some forms of the present technology, the 'path length' will be considered as the distance along the surface from f (0) to f (1), i.e. the distance along the path on the surface. There may be more than one path between two points on the surface and such paths may have different path lengths. (the imaginary path length of an individual will be the distance they travel along the path on the surface).

Straight line distance: the straight line distance is the distance between two points on the surface, but the surface is not considered. In the planar area, there may be a path on the surface having the same path length as the straight-line distance between two points on the surface. In a non-planar surface, there may be no path having the same path length as the straight-line distance between two points. (for an imaginary individual, the straight line distance will correspond to the distance as a 'straight line'.

5.4.6.3 space curve

Space curve: unlike planar curves, the spatial curves do not have to lie in any particular plane. The space curve may be closed, i.e. without end points. The space curve may be considered as a one-dimensional segment of three-dimensional space. A hypothetical person walking on one strand of a DNA helix walks along a spatial curve. A typical human left ear contains a helix, which is a left-handed helix, see fig. 3Q. A typical human right ear contains a helix, which is a right-hand helix, see fig. 3R. Fig. 3S shows a right-handed helix. The edges of the structure, e.g. the edges of the membrane or impeller, may follow a space curve. In general, a spatial curve may be described by curvature and torsion at each point on the spatial curve. Torque is a measure of how the curve rotates out of plane. The torque is signed and sized. The torsion at a point on the spatial curve can be characterized with reference to tangential vectors, normal vectors, and double normal vectors at that point.

Tangent unit vector (or unit tangent vector): for each point on the curve, the vector at that point specifies the direction from that point and the magnitude. The tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If an imaginary person flies along a curve and falls off his aircraft at a certain point, the direction of the tangential vector is the direction she will travel.

Unit normal vector: this tangent vector itself changes as the hypothetical person moves along the curve. The unit vector pointing in the direction of change of the tangent vector is referred to as a unit principal normal vector. It is perpendicular to the tangential vector.

Double normal unit vector: the double normal unit vector is perpendicular to both the tangent vector and the main normal vector. Its direction may be determined by a right-hand rule (see, e.g., fig. 3P) or alternatively by a left-hand rule (fig. 3O).

Close plane: a plane containing the unit tangent vector and the unit principal normal vector. See fig. 3O and 3P.

Torsion of space curve: the twist at a point of the space curve is the magnitude of the rate of change of the double normal unit vector at that point. It measures how far the curve deviates from the plane of close. The space curve lying in the plane has zero torsion. A space curve that deviates from the approach plane by a relatively small amount will have a relatively small amount of twist (e.g., a gently sloping helical path. A space curve that deviates from the close plane by a relatively large amount will have a relatively large amount of twist (e.g., a steeply sloping helical path.) referring to fig. 3S, the amount of twist near the top coil of the helix of fig. 3S is greater than the amount of twist of the bottom coil of the helix of fig. 3S due to T2> T1.

Referring to the right-hand rule of fig. 3P, a space curve directed toward the right-hand side double normal direction may be considered to have a right-hand positive twist (e.g., the right-hand spiral illustrated in fig. 3S). The space curve turning away from the right hand double normal direction may be considered to have a right hand negative twist (e.g., left hand spiral).

Likewise, referring to the left hand rule (see fig. 3O), a space curve directed toward the left hand double normal direction may be considered to have a left hand positive twist (e.g., a left hand spiral). The left hand is therefore positive and equivalent to the right hand negative. See fig. 3T.

5.4.6.4 hole

The surface may have one-dimensional holes, for example holes defined by planar curves or by space curves. A thin structure (e.g., a film) with holes can be described as having one-dimensional holes. See, for example, the one-dimensional holes in the planar curve-bordered surface of the structure shown in fig. 3I.

The structure may have two-dimensional apertures, such as apertures defined by surfaces. For example, pneumatic tires have a two-dimensional aperture defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel may have a two-dimensional aperture. For example, referring to the pad of fig. 3L and the exemplary cross-sections through fig. 3M and 3N, the interior surfaces defining a two-dimensional aperture are shown. In yet another example, the conduit may include a one-dimensional aperture (e.g., at its inlet or at its outlet) and a two-dimensional aperture defined by an inner surface of the conduit. See also the two-dimensional aperture in the structure shown in fig. 3K bounded by the shown surfaces.

5.5 other remarks

Unless the context clearly indicates and provides a range of values, it is understood that every intermediate value between the upper and lower limits of the range, to one tenth of the unit of the lower limit, and any other such value or intermediate value within the range, is broadly encompassed within the technology. The upper and lower limits of these intermediate ranges may independently be included in the intermediate ranges, and are also encompassed within the technology, subject to any specifically excluded limit in the range. Where the range includes one or both of the limits, the art also includes ranges excluding either or both of those included limits.

Furthermore, where a value or values described herein are implemented as part of the technology, it is to be understood that such value or values may be approximate unless otherwise stated, and that such value or values may be used for any suitable significant digit to the extent that practical technical implementations may allow or require it.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of representative methods and materials are described herein.

Obvious replacement materials with similar properties are used as alternatives to the specific materials identified for constructing the component. Moreover, unless specified to the contrary, any and all components described herein are understood to be capable of being manufactured and thus may be manufactured together or separately.

It must be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural equivalents thereof unless the context clearly dictates otherwise.

All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and/or materials which are the subject matter of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the art is not entitled to antedate such publication by virtue of prior invention. Furthermore, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

The terms "include" and "comprising" are to be understood as: to each element, component, or step in a non-exclusive manner, indicating that the referenced element, component, or step may be present or utilized, or combined with other elements, components, or steps that are not referenced.

The topic headings used in the detailed description are for convenience only to the reader and should not be used to limit the topics that can be found throughout this disclosure or claims. The subject matter headings are not to be used to interpret the scope of the claims or limitations of the claims.

Although the technology has been described herein with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some instances, the terms and symbols may imply specific details not required to practice the present technology. For example, although the terms "first" and "second" may be used, they are not intended to represent any order, unless otherwise indicated, but rather may be used to distinguish between different elements. Furthermore, although process steps in a method may be described or illustrated in a certain order, this order is not required. Those skilled in the art will recognize that this sequence may be modified and/or that aspects thereof may be performed simultaneously or even synchronously.

It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present technology.

5.6 reference symbol list

Feature item numbering

Patient 1000

Bed partner 1100

Patient interface 3000

Non-invasive patient interface 3000

Seal forming structure 3100

Plenum chamber 3200

Positioning and stabilizing structure 3300

Vent 3400

Connection port 3600

Forehead support 3700

RPT device 4000

Air circuit 4170

Humidifier 5000

Patient interface 6000

Seal forming structure 6100

Cushioning assembly 6150

Inflatable chamber 6200

Headband 6300

Rear headgear strap 6310

Tube 6350

Intermediate conduit portion 6352

Lip 6354

Orifice 6355

Adjustment mechanism 6360

Telescopic tube section 6362

Connection port 6600

Connector assembly 7600

Elbow assembly 7700

Elbow member 7710

First end 7712

Tubular end 7713

Second end 7714

Recess 7715

Side recess 7715S

Upper concave 7715U

Lug 7716

Tubular end 7717

Channel 7717C

Stop 7719

Vent 7720

Ridge 7722

Flange 7722

Shelf 7723

Clip member 7730

Clamping arm 7740

Fastening portion 7750

Buckle 7755

Recess 7757

Connecting portion 7760

Button portion 7780

Finger grip 7781

Spin-on connector 7790

Protrusion 7795

Ring member 7900

Seal groove 7905

Taper 7907

First side 7910

First flange 7915

Second side 7920

Second flange 7925

Channel 7930

Clip flange 7940

Ramp 7941

Clip channel 7945

Sealing member 7950

Connection 7952

Sealing portion 7954

Elbow assembly 8700

Elbow member 8710

Clip member 8730

Connecting portion 8760

Claims

1. A patient interface for delivering an air flow at a positive pressure relative to ambient air pressure to an entrance to an airway of a patient while the patient is sleeping, the patient airway including at least an entrance to a nostril of the patient to ameliorate sleep disordered breathing, the patient interface comprising:

a seal-forming structure constructed and arranged to form a seal with a region of a patient's face surrounding an entrance to the patient's airway;

a positioning and stabilizing structure providing a force that maintains the seal-forming structure in a therapeutically effective position on the patient's head; and

a connector assembly configured to connect to an air circuit, the connector assembly comprising:

a ring member configured to be removably and releasably secured in an aperture of an attachment region of the patient interface; and

an elbow assembly configured to be connected to the air circuit, the elbow assembly being repeatedly connectable to and disconnectable from the ring member,

The elbow assembly includes an elbow member and a clip member, the clip member comprising a separate and distinct structure from the elbow member,

wherein the elbow member and the clip member comprise separately molded components that are subsequently connected to each other,

wherein the elbow member includes an outer surface disposed outside of an airflow path formed through the elbow member,

wherein the outer surface of the elbow member includes a recess constructed and arranged to receive at least a portion of the clip member, an

Wherein the clip member is configured and arranged to releasably connect the elbow assembly to the ring member, and the elbow member is configured and arranged to form a seal with the ring member when the elbow assembly and the ring member are connected to one another.

2. A patient interface according to claim 1, wherein the clip member is constructed and arranged to provide a separable snap-fit assembly with the ring member.

3. A patient interface according to any one of claims 1-2, wherein the elbow member comprises a 90 ° bend.

4. The patient interface according to any one of claims 1-2, further comprising a swivel connector provided to the elbow member, the swivel connector configured to connect to the air circuit.

5. A patient interface according to any one of claims 1-2, wherein the clip member comprises a pair of resilient quick release clip arms and a connection interconnecting the clip arms.

6. A patient interface according to claim 5, wherein each of the clamping arms comprises a snap portion and a button portion, each snap portion comprising a snap configured to provide a snap-fit coupling assembly with the ring member.

7. A patient interface according to claim 5, wherein the recess of the elbow member includes an upper recess configured to receive the connection portion and a side recess configured to receive a corresponding clamping arm.

8. A patient interface according to claim 7, wherein each of the side recesses comprises a lug configured and arranged to interact with a respective one of the clamp arms to facilitate retaining the clamp member on the elbow member and operating the clamp arms.

9. A patient interface according to any one of claims 1-2, wherein the ring member includes a sealing member and the elbow member includes a tubular end configured to extend through the ring member and engage with the sealing member to provide a sealed gas flow path for delivering pressurized gas through the elbow assembly to the patient interface.

10. A patient interface according to any one of claims 1-2, wherein the elbow member includes a plurality of ventilation holes to allow exhaust gas to escape from the patient interface.

11. A patient interface according to any one of claims 1-2, wherein the elbow member is constructed of a material that is more rigid than a material of the clip member.

12. A patient interface according to any one of claims 1-2, wherein the ring member includes first and second flanges forming a channel that sealingly engages the attachment region of the patient interface.

13. A patient interface according to any one of claims 1-2, wherein the ring member includes a clip flange configured and arranged to engage the clip member when the elbow assembly is releasably connected to the ring member.

14. A patient interface according to claim 13, wherein the clip flange forms a clip channel configured and arranged to matingly receive a catch of the clip member.

15. A patient interface according to claim 13, wherein the clip flange provides an angled surface in an assembly direction to facilitate push assembly of the elbow assembly onto the ring member.

16. A patient interface according to any one of claims 1-2, wherein the elbow assembly and the ring member form a swivel connection that allows 360 ° free rotation of the elbow assembly relative to the ring member.

17. A patient interface according to any one of claims 1-2, wherein the positioning and stabilizing structure comprises two tubes.

18. A patient interface according to claim 17, wherein the attachment region is configured and arranged to fluidly connect the two tubes.

19. A patient interface according to any one of claims 1-2, further comprising a retaining arrangement constructed and arranged to connect the clip member to the elbow member.

20. A patient interface according to claim 19, wherein the retaining arrangement comprises a snap-fit assembly.

21. A CPAP system for treating sleep disordered breathing, the CPAP system comprising:

a CPAP device configured to supply a flow of positive pressure air;

a patient interface according to any one of claims 1-20; and

an air circuit connected between the CPAP device and the patient interface to deliver the flow of air at the positive pressure from the CPAP device to the patient interface.